Careers

NATURE & SCOPE 

Associate Chemist will perform, under supervision of the Laboratory Manager: enzyme activity assays and other advanced chemical analysis or samples submitted to SORA Labs.  A successful candidate will be expected to maintain accurate and legible laboratory notebooks and perform testing in accordance with applicable SOP’s and with FDA, OSHA, EPA, and ISO standards and regulations. 

MAJOR ACCOUNTABILITIES 

The responsibilities of the Associate Chemist include, but are not limited to, the following: 

General Responsibilties 

• Local travel (between sites): N/A

• Out of state travel: None

Work Responsibilities: 

• Perform and report the assigned testing of samples submitted to the laboratory.

• Perform advanced chemistry instrumentation operation, maintenance and calibrations programs including HPLC, GC, FTIR, ICP or other equipment as assigned.

• Plan, coordinate and conduct in vitro testing research methodologies and assist in testing customer specific methods.

• Perform, develop, validate, and improve testing methodologies and assist in testing customer specific methods.

• Review and improve method modifications for improved peak separation.

• Perform testing in support of OOS investigations.

• Record and peer-review analytical and calibration work performed as required for GMP and GLP accountability.

• Maintain the laboratory record-keeping systems necessary for regulatory and ISO compliance.

• Properly handle and dispose of all hazardous waste generated during routine functions.

• Cross-train staff on job functions to ensure continual lab operation and avoid delay of testing.

NATURE & SCOPE 

Assistant Chemist/Microbiologist will perform, under supervision of the Laboratory Supervisor: chemical, microbiological, and physical testing of samples submitted to the laboratory. A successful candidate will be expected to maintain accurate and legible laboratory notebooks and perform testing in accordance with applicable SOP’s and with FDA, OSHA, EPA, and ISO standards and regulations. 

MAJOR ACCOUNTABILITIES 

The responsibilities of the Assistant Chemist/Microbiologist include, but are not limited to, the following: 

General Responsibilities

• Local travel (between sites): Occasional (< 25%)

• Out of state travel: None

Work Responsibilities: 

• Perform the receipt, compositing, and organization of samples submitted to SORA Labs. Perform sampling in a GMP environment.

• Perform and report the assigned testing of samples submitted to the laboratory.

• Perform testing in support of OOS investigations.

• Perform and report the routine maintenance and calibration of equipment and instrumentation.

• Record and peer-review analytical and calibration work performed as required for GMP and laboratory accountability.

• Organize and maintain the necessary chemical and reagent stocks.  Maintain the laboratory facilities in a clean and organized manner.

• Properly handle and dispose of all hazardous waste generated during routine function.

• Perform duties in accordance with FDA, OSHA, EPA, and ISO standards and regulations.

The primary function of this role is to manage and be accountable for achieving the forecasted sales and margin targets for the territory by developing and maintaining current business to business accounts and to consistently seek out and establish new business for the company.

MAJOR ACCOUNTABILITIES

• Achieve budgets, sales and margin targets

• Develop and manage territorial sales and forecasts

• Generate new business from both existing and new accounts; be objective and budget driven

• Prepare, propose, and implement an annual sales plan for the assigned territory

• Insure updates of sales and prospect list are reported monthly.

• Achieve a prospect close ratio as agreed upon with VP of Sales

• Must issue price increase activities as warranted, in a timely manner

• Must maintain and manage sales opportunities, contacts and prospects using current CRM

• Rigorous tradeshow preparation is mandatory; insure tradeshow meetings with new and existing customers are relevant and  highly productive

• Follow up with VP of Sales on tradeshow prospects; bi-weekly progress reports are mandatory

• Improve quality of proactively generated quotes and improve closure rate as agreed upon with VP of Sales; measured by monthly scorecard

• Develop objectives, strategies, and tactics to improve market share

• Seek out and reports competitive information to effectively position our products

• Submit timely call reports via CRM, expense accounts, weekly prospect updates

• Ability to understand and meet necessary deadlines

WORKING CONDITIONS

• Must be willing and able to travel to customers by car or where justified by air

• Must be able to work out of a home office without supervision

The Associate Analytical Chemist will work, under minimal supervision of the Analytical Chemistry Manager, on production of microorganisms and various short- and long-term projects (in-house and outside requests). The incumbent will work in a hands-on capacity in the cGMP fermentation and production areas to manufacture Deerland Probiotics and Enzymes’ proprietary microorganisms and will investigate, validate, create, and develop new methods and technologies. He or she will be responsible for the Kennesaw fermentation manufacturing facility and utility areas, including new equipment and/or systems installations, and equipment, systems, and process improvement initiatives. The successful candidate will lead the optimization of fermentation processes/output for microorganisms, lead internal and customer driven research projects, and effectively communicate in customer-friendly reports, technical reports, and presentations, for co-workers, customers, or at scientific conferences as necessary. The Associate Analytical Chemist will be responsible for new equipment management of change, corrective and preventative actions (CAPAs), and technical documentation. He or she will maintain accurate and timely record of test results; perform standard and complex laboratory procedures; work collaboratively with various departments to compile, analyze, and interpret data.

The responsibilities of an Associate Analytical Chemist include, but are not limited to, the following:

Key Responsibilities

• Fermentation of microorganisms’ at Deerland’s Kennesaw location

• Oversee the development, optimization, validation, implementation, and training of SOPs, cGMP regulations regarding fermentation, guidelines, and safety procedures

• Author and implement change controls associated with fermentation and support equipment, processes, and utilities

• Contribute to project from inception to completion / revenue generation

• Improve and expand company’s knowledge of new ingredients / technologies for new and existing markets as applicable

• Develop, optimize/validate, and implement a variety of laboratory techniques and/or protocols for Analytical Chemistry/Quality Control/Quality Assurance

• Develop, as warranted, prototypes for range of products based on company’s technology

• Collaborate with industry professionals to expand new application development opportunities

• Provide leadership, motivation, and a performance-based culture within the technology team

General Responsibilities

• Participate in interdepartmental cross-training to assist within the Analytical Chemistry, Research and Development, Quality Assurance, and Quality Control Departments

• Comply with SOPs, batch records, and controlled documentations

• Maintain and operate fermenters, sterilize equipment, and prepare production media

• Ensure compliance with cGMP regulations, guidelines, and safety procedures

• Collaborate with R&D, QC, Clinical departments to compile, analyze, and interpret data

• Maintain familiarity with current scientific literature and contribute to the process of intra/interdepartmental projects

• All other assigned duties

• Local travel (between sites): 50-75%

• Out of state travel: Occasional (<5%)

• Learn the operator roles and responsibilities and SOPs specific to the assigned area and equipment.

• Complete all required batch records and forms in an accurate and timely manner.

• Operate assigned equipment in a safe, productive and timely manner.

• Perform machine changeover and cleaning as specified by the production schedule in accordance with the appropriate SOPs.

• Weigh, count, document and verify raw materials used in the assigned production area.

• Ensure products in assigned area are produced according to the batch record and specifications.

• Clean assigned equipment and rooms according to SOPs in a timely manner.

• Accurately maintain the correct data input for the VORNE system in your area in order to monitor the equipment's’ overall efficiency.

• Adhere to company rules and safe work practices within the department.

• Keep work area clean and organized.

Description:

QC Laboratory Supervisor will, under minimal supervision of the Director of Quality, oversee inspection and analysis on raw materials, in-process samples, and finished goods to ensure compliance with cGMP/GLP standard operating procedures. The scope of responsibility for this position crosses multiple departments within Deerland (e.g. Quality Assurance, Production, Sales, etc.); therefore, the incumbent needs to collaborate with various departments and institutions. The QC Laboratory Supervisor will lead, facilitate, and support the improvement of staff through regular communication regarding expectations, laboratory technique, and training. A successful candidate will be expected to review laboratory logbooks and testing documentation for accuracy and legibility in accordance with SOP's. Additional functions include reviewing and creating Certificates of Analysis (COAs) and Result Reports; provide technical support to internal and external customers and/or vendors; support customer acquisition testing including chemical assays and microbiological assays.

Full line: 5-15 Direct Reports

Member of: Compliance

Management:

• Lead and manage department staff through effective planning, mentoring, directing and coordination of development activity

• Lead and facilitate initial and periodic training of QC Chemists, Microbiologists to ensure standard laboratory practices, techniques, and adherence to cGxP and other applicable regulations and standards (21 CFR, §11, §111 and §117, ISO17025 and the requirements of TGA PIC/s)

• Oversee the development, transfer, improvement, validation, and implementation of new laboratory methods

• Lead or assist in the development of all laboratory standard operating procedures

• Communicate and enforce laboratory quality requirements to all personnel working in the lab and ensure that they are completed per GMP, GLP and ISO 17025 standards

• Monitor adherence to the laboratory budget and provide reports, as required, to department administration

• Develop and drive budgetary cost reduction strategies.

• Prepare and perform personnel evaluations and competencies and administer performance reviews.

• Provide improvement plans/disciplinary action where necessary

• Coordinate objectives with production procedures in cooperation with other managers to maximize

product reliability and minimize costs

• Ensure a timely and effective communication and escalation process exist to raise quality issues to the appropriate levels of management.

• Record, interpret, and present results to senior colleagues, customers, and vendors

• Local travel (between sites): Frequent ( greater than 50%)

• Out of state travel: Occasional ( less than 10%)

Quality Control Responsibilities

• Oversee the scheduling and performance of laboratory tests in a manner such that results are accurate, precise, and reproducible

• Oversee (including approving or rejecting) the inspection and analysis of raw materials (including packaging components), in-process samples, and finished goods and ensure that it is conducted in accordance with cGMP/GLP standard operating procedures

• Lead investigations related to contamination and procedural or analytical deviations or errors in the laboratory and ensure corrective actions are developed and implemented

• Oversee the validation, qualification, maintenance and repair of laboratory and testing equipment, ensuring all maintenance and repairs are adequately performed, documented, and reviewed for compliance with design specifications.

• Review and approve all laboratory control processes associated with the production and process control system

• Ensure all tests and examinations required under 111.75 are conducted and results delivered in accordance to established timelines.

• Determine whether specifications established under 111.70(a) are met

• Review and approve the results of all tests and examinations required under 111.75

• Conduct material review and disposition decisions if an established specification is not met.

• Document all material review and disposition decisions at the time of performance

• Ensure laboratories are well-stocked and resourced via maintenance of reagent and equipment stock and ordering of necessary materials

• Coordinate with laboratory vendors for supply or equipment issues, new equipment or supply purchases and annual cost reviews

• Create, analyze, verify, and approve result reports

• Create, verify, and sign-off on COAs upon successful finished goods testing

• Oversee proper storage of retains

• Enforce proper laboratory safety protocols and regulatory requirements for OSHA, NSF, and other agencies Deerland Probiotics and Enzymes is associated with (e.g. ISO)

• Maintain familiarity with current scientific literature and technologies

• Approve and monitor any contract labs, analysts, or other providers of GMP related outsourced activities

• Act in partnership with the Quality Manager to lead all ISO 17025 and regulatory audits related to the laboratory operation

• Submit performance improvement initiatives and drive efficiencies and continuous improvement within the laboratory operation

• Other Duties as Required

Nature & Scope:

The Quality Control Microbiologist prepares and tests samples from all phases of a manufacturing or other handling process, with the goal of determining if the substance meets the microbial limits or requirements of the project. They perform a variety of microbial methods that can vary but generally require basic microbiological and laboratory skills and a general understanding of microbial identification. The scope of responsibility for this position crosses multiple departments, therefore the incumbent shall collaborate with various departments. They have a role in preserving workplace safety and safe materials handling as appropriate, since they sometimes work with hazardous materials.

Major Accountabilities:

The responsibilities of the QC Microbiologist include, but are not limited to the following:

• Testing and release of finished products, stability samples, raw materials, registration, clinical and marketed products batches under GMP/GLP environment as per company's standard operating procedures and USP/FDA guidelines.

• Prepare reagents, samples, and standards according to procedures.

• Maintain up to date documentation. Enter all raw data directly into the notebook and promptly calculate all test results.

• Document testing, observations, deviations, OOS investigation and results clearly and completely.

• Schedule, request and execute the QC inspection tests and/or experiments.

• Peer review notebooks and test results generated by other QC team members.

• Critically evaluate and interpret experimental data. Immediately inform supervisor of issues and assist in the resolution of complex problems.

• Maintain laboratory equipment and instrumentation in good working order, following appropriate procedures for usage, clean-up and maintenance.

• Maintain and follow all laboratory systems, GMPs, safety and housekeeping requirements.

• Teach, train, coach, and advise other QC team members on microbiological techniques and methods.

• Prepare and review SOPs, as required.

• Perform Quality Inspection functions, assist with water sampling and monitoring.

• Support sampling and testing for cleaning validation, process validation and method validation as required.

• Maintain familiarity with current scientific literature and technologies.

MAJOR ACCOUNTABILITIES

• Learn the operator roles and responsibilities and SOPs specific to the assigned area and equipment.

• Complete all required batch records and forms in an accurate and timely manner.

• Operate assigned equipment in a safe, productive and timely manner.

• Perform machine changeover and cleaning as specified by the production schedule in accordance with appropriate SOP`s.

• Weigh, count, document and verify raw materials used in the assigned production area.

• Ensure products in assigned area are produced according to the batch record and specifications.

• Clean assigned equipment and rooms according to SOPs in a timely manner.

• Accurately maintain the correct data input for the VORNE system in your area in order to monitor the equipment overall efficiency

• Adhere to company rules and safe work practices within the department.

• Keep work area clean and organized.

• Learn the operator roles and responsibilities and SOPs specific to the assigned area and equipment.

• Perform machine setup and adjustment to ensure product meets specifications.

• Perform machine changeover and cleaning as specified by the productions schedule in accordance with appropriate SOPs.

• Complete all required batch records and forms in an accurate and timely manner.

• Operate assigned equipment in a safe, productive and timely manner.

• Weigh, count, document and verify raw materials used in the assigned production area.

• Ensure products in assigned area are produced according to the batch record and specifications.

• Clean assigned equipment and rooms according to SOPs in a timely manner.

• Accurately maintain the correct data input for the VORNE system in your area in order to monitor the equipment overall efficiency.

• Adhere to company rules and safe work practices within the department.

• Keep work area clean and organized.

NATURE & SCOPE 

The Sanitation Coordinator, will be responsible for sanitation practices throughout the facility. This includes Production Suites, laboratories, restrooms, offices, warehouse, other general areas and grounds as needed in order to maintain and conform to FDA and cGMP guidelines and regulations for cleaning practices. GMP training and training on specialized equipment will be provided. Works with Production Operators to maintain Production Suite environment below alert limits by following established cleaning practices. The sanitation practices performed must conform to the regulations set forth by all legislature.

MAJOR ACCOUNTABILITIES 

• Responsible for coordinating, monitoring and updating documents, forms and logs in relation to cleaning/ sanitation functions

• Following established techniques and using designated solutions, cleans and washes walls, ceilings, inside and outside windows, equipment exteriors, carts, tables, chairs, stools, benches, door handles, door push plates, door latch releases, light switches, telephones, floors, and window blinds.

• Responsible for preparation of solutions, solution disposal, trash disposal. Administrative and laboratory cleaning includes vacuuming carpets and removes stains and foreign matter from a variety of surfaces using proper cleaners.

• Moves office furniture and equipment for cleaning. Sweeps, mops, strips, scrubs, and polishes floors using industrial power equipment

• Partner with Production, Maintenance and Quality Departments to ensure that all sanitation and pest control programs, procedures and systems are effectively developed, executed and monitored per policy requirements

• Washes and cleans windows and ceiling air vents. Dusts and cleans office areas, woodwork, furniture, floor coverings, fixtures, fire doors, and empties trash containers.

• Cleans and disinfects rest rooms, keeps paper and sanitation supplies on hand. Provides general cleanup outside of buildings.

• Works with Quality Manager to maintain the Pest Control Log.

• Facilitate corrective actions related to pest prevention and sanitation

• Monitor and maintain inventory levels of sanitation supplies, including ordering and replenishing.

• Maintain and log on all sanitation on Master Cleaning Schedules.

• Mixes/Handles chemical concentrates.

• Assists with various special projects as assigned by Management.

• Monitors cleanliness behind/ below facility pallets and racking.

• Works with Maintenance Dept. to make minor interior wall repairs and touch up paint.

• Utilizes powered cleaning equipment that may include lift truck, scissors lift, power washer, foam applicators, automatic compactors and various non-mechanized equipment. 

• Follows safety rules including but not limited to safe lifting, lock out/tag out wearing proper PPE (Personal Protective Equipment), following l Safety Data Sheets, proper disassembly and reassembly of equipment.

• Participates in all necessary safety training, team development programs, and plant initiatives.

• Creates/Updates Standard Operating Procedures.

• Perform zonal inspections each week to cover the entire facility once per month searching for opportunities pertaining to sanitation and sanitary design

• Focus on sanitation optimization and effectiveness as well as project design and verification

• Other duties relating to facility operation and sanitation, as assigned.

MAJOR ACCOUNTABILITIES

Will perform all changeovers in the respective area to ensure they are done correctly and in a timely manner.

• Learn the operator roles and responsibilities and SOPs specific to the assigned area and equipment.

• Complete all required batch records and forms in an accurate and timely manner.

• Perform machine changeover and cleaning as specified by the production schedule in accordance with appropriate SOP`s.

• Operate assigned equipment in a safe, productive and timely manner.

• Weigh, count, document and verify raw materials used in the assigned production area.

• Ensure products in assigned area are produced according to the batch record and specifications.

• Clean assigned equipment and rooms according to SOPs in a timely manner.

• Adhere to company rules and safe work practices within the department.

• Keep work area clean and organized.

Nature & Scope:

The Quality Assurance Technician is responsible for ensuring the quality of raw materials and finished goods used by and/or manufactured at Deerland Enzymes. The primary function of this role is to be a "hands on" technician that performs quality assurance and control functions and assist in compliance with internal and external regulations, protocols, and policies.

Major Accountabilities:

• Ensure facility and products meet all local and federal food/supplement safety regulations

• Act as a facilitator/coach in areas such as Quality Control techniques, Good Manufacturing Practices, and product quality/safety

• Sample and analyze raw materials, in process goods, and finished products to assure compliance to specifications

• Perform cleaning validations and line clearance using, but not limited to, ATP/ NADH technologies

• Assist with quality team audits including, but not limited to, Good Manufacturing Practices and HACCP

• Record and evaluate test data, alerting Director of QA/QC to any deviations from specifications

• Assist in data collection and analysis for ongoing quality improvements

• Partner with plant operations, maintenance, quality and engineering to develop, write, review and train on Standard Operating Procedures and Policies, Work Instructions, and Forms programs are effective for producing a safe food/supplement products and to facilitate the successful execution of customer, regulatory, and certification audits

• Perform document control activities including, but not limited, issuing master manufacturing records, review and approving batch records and work instructions, ensuring logs and records are appropriately completed and maintained, reviewing and approving shipping documentation, and filing and maintaining all records as required

• Review and approve lab analysis reports for the approval of raw materials, in process products, and finished goods

• Follow and enforce all company GMPs and SOPs

• Other duties as assigned as needed

The primary function of this role is to assist with the management and oversight of the good manufacturing practices and the quality of raw materials and finished goods used by and/or manufactured at Deerland Probiotics and Enzymes. This role is to be a “hands on” supervisor that oversees and performs quality assurance functions and assists in compliance with internal and external regulations, protocols, and policies.

MAJOR ACCOUNTABILITIES 

• Ensure cGMP standards are properly implemented and carried out throughout the organization.

• Ensure that the facility and products meet all local and federal food/supplement safety regulations

• Act as a facilitator/coach in areas such as Quality techniques, Good Manufacturing Practices, and product quality/safety

• Assist with employee reviews and facilitate coaching sessions

• Sample and analyze raw materials, in process goods, and finished products to assure compliance to specifications

• Perform line clearance using, but not limited to, ATP technologies

• Assist or conduct audits with the Quality team including, but not limited to, Good Manufacturing Practices and Food Safety

• Record and evaluate test data, alerting Director of Quality to any deviations from specifications

• Assist in data collection and analysis for ongoing quality improvements

• Partner with plant operations, maintenance, compliance, quality and engineering to ensure that good manufacturing practices, sanitation and pest control programs, procedures and systems are effectively monitored per policy requirements

• Partner with plant operations, maintenance, quality and engineering to develop, write, review and train on Standard Operating Procedures and Policies, Work Instructions, and Forms

• Partner with operations team to build a strong food safety culture, to ensure pre-requisite programs are effective for producing a safe food/supplement products and to facilitate the successful execution of customer, regulatory, and certification audits

• Assist in performing quality document activities including, but not limited, issuing master manufacturing records, review and approving batch records and work insturctions, ensuring logs and records are appropriately completed and maintained, reviewing and approving shipping documention, and filing and maintaining all records as required

• Ensure new / revised SOPs and continuous improvement efforts are communicated and implemented.

• Other duties as assigned

SUMMARY:  

Install, maintain and repair machinery, equipment and physical structures of the company.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Visually inspect and test machinery and equipment.

2. Listen for unusual sounds from machines or equipment to detect malfunction and discuss machine operation variations with the manager or other maintenance personnel to diagnose the problem or repair the machine.

3. Dismantle defective machines and equipment and install new or repaired parts.

4. Clean and lubricate shafts, bearings, gears and other parts of machinery.

5. Install and repair electrical and electronic apparatus, such as transformers and wiring, and electrical components of machinery and equipment.

6. Maintain control of parts and the computer tracking system.

7. Maintain pipe systems and related hydraulic and pneumatic equipment.

8. Repair and replace gauges, valves, pressure regulators and related equipment.

9. Install, program, or repair automated machinery and equipment such as programmable logic controllers.

10. Set up and operate machine tools such as lathe, grinder, drill and milling machine to repair or fabricate machine parts, jigs and fixtures and tools.

11. Operate welding equipment to cut or join metal parts as required.

12. Maintain test, measurement, and diagnostic equipment.

Non-Essential Responsibilities:

 Maintain parts inventory.

• 2. Assist machine operators with non-technical questions.
• 3. Perform other duties as requested by management.

EQUIPMENT USED:

Welding equipment, cutting tools, pallet jack, floor and table top scales, grinder, drill press, lathe, hand tools, copy machine, telephone, and computer.

NATURE & SCOPE 

Physical loading and unloading of materials at any given warehouse facility. Transporting materials between warehouse facilities. General warehouse duties.

MAJOR ACCOUNTABILITIES 

The responsibilities of the Warehouseman- Transporter include; but are not limited to, the following: 

General Responsibilities

• Local travel (between sites): 50%

• Must possess a valid class E Driver’s License

• Attendance is key to performing the job. 

Essential Responsibilities: 

• Directly responsible for the physical transfer of all non-stock items and raw materials to meet manufacturing schedules.  

• Responsible for the physical receiving in of new materials, both raw and non-stock items at main warehouse facilities. Follow necessary SOP’s to perform these duties.

• Responsible for double checking of all staged raw materials that are to be loaded and transferred to Blending, Encapsulation, and Packaging. Responsible for physically loading materials into company vehicle for transfer. Responsible for stocking and restocking of incoming raws (new or returned). Includes weight verification and/or counts and documenting said weight/counts.

• Directly responsible for unloading transferred materials from company vehicle to proper or assigned staging areas. Includes placing raw materials in proper bin locations at Warehouse #2 & #3.

• Responsible for recording bin locations in DS90.

• Assist Warehouse Supervisor in maintaining paperwork and executing PO receipts and Non-PO receipts.

• Assist Shipping with the delivery of non-stock items to appropriate personnel or areas.

• Assist the Warehouse Supervisor with the loading and unloading of freight.  

• Directly responsible for the return of raw materials from Blending and Packaging to appropriate warehouse for re-binning and re-stock.

• Report any maintenance issues to the Warehouse Supervisor.

• Responsible for any and all documentation of transfers of materials.

• Responsible for upkeep of warehouse facilities and machinery used at warehouse. Duties will be assigned by Warehouse Supervisor. These duties include but are not limited to the following: sweep Warehouse 2, 3, empty trash containers; empty cardboard dumpster; dust and mop as needed.

• Assist Warehouse Supervisor with stocking and restocking of incoming raws (new or returned). This will include weight verification and/or counts, and documenting said weight/counts. Paperwork will be turned over to Warehouse Supervisor.

• Share responsibility of daily forklift checks, including batteries and maintenance and record keeping of this activity. Notify Warehouse Supervisor with any problems involving forklift.

• Directly responsible for weight verifications/counts requested by the Warehouse Supervisor.

• Directly responsible for requisitioning materials to fill incoming/outgoing orders (picks) for packaging.

• Directly responsible for weekly counts including but not limited to a capsule count, box and bottle count, and finished product count at warehouse 2 and 3.

• Will assist with Year-End Inventory.

• Conduct daily cycle counts and turns reports over to the Warehouse Supervisor.

• Responsible for staging of outgoing orders (picks) for transport.

• Other duties may be assigned by the Warehouse Supervisor.

NATURE & SCOPE 

The technical manager’s primary functions are to oversee, develop and validate new methods for routine use,

maintain instrumentation, provide technical guidance to staff and customers. Training staff on advanced instrumentation operation for the accurate method transfer to the quality control operations for a 3rd party testing lab. Duties will also include working with management in the evaluation of method development costs and on-going operational costs of running methods for routine testing where cost/benefit can be considered as methods are added to the lab.

MAJOR ACCOUNTABILITIES 

The responsibilities of the Associate Chemist include; but are not limited to, the following: The functions below are to be performed in accordance with all applicable FDA, OSHA, EPA, and ISO standards and regulations.

Responsibilities

• Provide technical advice regarding the following to include, but not be limited to: audits, methodologies, method development, instrumentation, and associated capabilities related to these areas.  

• Develop, validate, and implement advanced testing methodologies for instrumentation including HPLC, LC MS/MS, GC/MS, GC/FID, ICP, etc. and continuously improve methods as technology advances.  

• Develop, implement, and train staff with advanced laboratory instrumentation methods, operation, maintenance and calibration for equipment including HPLC, LC MS/MS, GC/MS, GC/FID, ICP or other chemistry instumentation.

• Advise on capabilities and assist on quoting projects using advanced equipment methods as needed for customers to submit samples for 3rd party contract chemistry testing. 

• Direct work, conduct performance appraisals, reward and/or discipline employees, address complaints and resolve problems. 

• Offer thorough equipment, reagent, supply lists, etc. to include what is needed for each method development project so accurate costs can be determined for return on investment decisions.  

• Review and release test results to customers to include a detailed technical explanation when applicable. 

• Respond to customer requests, inquiries, and complaints and perform investigations when required. 

• Design and perform special projects for internal and external customers. 

• Advise on and review sample submissions for business team to verify in house method capabilities or recommend outsource testing if testing specifications are below our internal equipment limit of quantitation.  

• Research compendia and be able to perform method transfers and /or method development activities following internal SOPs and comply with ISO, FDA, and TGA and other regulatory requirements.  

• Author and/or revise general methods needed for the implementation and transfer of the method to the QC department of our 3rd party testing lab following the proper documentation practices required. 

• Coordinate the proper maintenance, repair, calibration and operation of instrumentation following all ISO, FDA or other regulatory guidelines.

• Develop, implement and continuously improve the systems, procedures and record-keeping necessary for the organized and efficient receipt of samples for in-house chemistry testing. 

• Develop, implement, and control the systems, procedures and record-keeping necessary for the organized and efficient reporting, peer-review, and archiving of laboratory testing & calibration data. 

• Oversee the accuracy of test records and per-review analytical and calibration work performed as required for regulatory and ISO compliance.

• Troubleshoot anomalous results generated by the laboratory.  Perform testing in support of OOS investigations.  

• Maintain the safe and correct use and disposal of laboratory chemicals, solvents, etc., following all federal, state and local guidelines using GMP, GLP and other safe laboratory practices. 

• Perform other roles and responsibilities per the Quality Manual.