Performs quality control testing on all incoming components, ingredients, blends and finished goods in accordance with 21 CFR Part 111 for Dietary Supplements. Following cGMP’s, assists in herb and component sampling, reserve sample handling, and proper documentation. A dynamic position moving between a variety of tasks daily. May be asked to lead projects and assist in training of new employees.
Essential Duties & Responsibilities:
- Performs routine sampling of herb ingredients for QC lab analysis.
- Performs laboratory quality control testing on incoming components, ingredients, blends and finished products according to laboratory SOPs.
- Performs and reports microbial testing for incoming ingredients, finished products, environmental swabs and other samples as required.
- Updates laboratory documents, as needed.
- Reviews data from contract laboratories to ensure conformance.
- Reports test results and compares to established specifications and control limits.
- Communicates quality problems to the laboratory supervisor for review by QA and the Material Review Board.
- Participates in out-of-specification investigations.
- Other duties include, but not limited to, interpretation of data and report generation, establishing troubleshooting guides, training and qualification of other analysts, interpretation and application of compendial methods, performing routine stability studies.
- Identifies and troubleshoots equipment problems.
- Ensures lab cleanliness and safety standards are maintained.
- Responsible for additional lab or interdepartmental functions and special projects as assigned by supervisor.
- BA or BS in a scientific discipline; or minimum 3 years of analytical experience in food, dietary supplement or equivalent industry.
- GMP or ISO regulated industry experience preferred.
- Strong time management skills and cohesive teamwork within lab are necessary for this position.
- Good Documentation Practices, Good Laboratory Practices, Good Manufacturing Practices; Basic laboratory skills – analytical weighing, volumetric glassware, sterile handling, chemical safety; Basic Microbiology skills- aseptic sampling, ability to use an autoclave and to count colony forming units.
- Basic math skills –ability to perform basic calculations and unit conversions
- Computer skills – Microsoft Outlook, Word, EXCEL, ERP experience
- Must be fluent in English, bilingual in Spanish helpful
- Analysts must be able to communicate effectively and efficiently with all other departments and employees.
- The job setting is in a manufacturing facility and offsite warehouse. All employees entering the manufacturing floor must have long pants, closed-toe shoes, and no jewelry. Primarily the Lab Coordinator will be located in the administrative area of the lab. Occasionally the Lab Coordinator may be asked to attend meetings/trainings at Rohnert Park office.
- Must be able to lift up to 40-50 lbs. Must be able to push/pull up to 20 lbs of force. At times, be able to bend and work with hands above shoulder level. Must be able to be on his/her feet for up to 5 hours.
- This position may require regular travel between our Santa Rosa warehouse and the manufacturing facility. As needed, he/she may have to travel between our headquarters in Rohnert Park and the manufacturing facility.