The Quality Control Laboratory Technician II ensures the safety, quality, and compliance of dietary supplement and cosmetic products by performing chemical and microbiological testing in accordance with Current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Part 111. Based in Tampa, Florida, this role involves analyzing raw materials, in-process samples, finished products, and environmental samples to confirm identity, detect microbial contamination, and support regulatory compliance and product integrity, including chemical identity testing via FTIR (Fourier Transform Infrared Spectroscopy). The technician reports to the Quality Control (QC) Manager in a dynamic manufacturing environment.

Position Responsibilities

1. Sample Testing: Collect and test raw materials (e.g., botanical extracts, vitamins, minerals), in-process blends, finished dietary supplements, and packaging components for microbial contamination (e.g., total aerobic count, yeast, mold, pathogens like E. coli, Salmonella, and Staphylococcus aureus).

2. Chemical Identity Testing: Perform FTIR (Fourier Transform Infrared Spectroscopy) analysis on incoming raw materials for identity confirmation, including spectral library searching/matching, interpretation of spectra, and troubleshooting of atypical or inconclusive results.

3. Environmental Monitoring: Conduct routine swabbing and air sampling of manufacturing areas, equipment, and water systems in the Tampa facility to ensure compliance with GMP cleanliness standards; analyze results against microbial limits.

4. Method Execution: Perform microbial assays per USP <61>/<2021> (Microbial Enumeration Tests) and USP <62>/<2022> (Tests for Specified Microorganisms), adhering to validated protocols.

5. Sample Preparation: Prepare media (e.g., agar plates, broths) and perform growth promotion testing to verify media suitability; process samples using aseptic techniques to prevent cross-contamination in a controlled lab setting.

6. Equipment Maintenance: Operate and maintain laboratory equipment (e.g., FTIR instrument, incubators, autoclaves, laminar flow hoods, microscopes) and perform regular calibration, qualification, and cleaning per SOPs.

7. Data Documentation: Record test results, deviations, and observations in laboratory notebooks and logbooks in accordance with Good Laboratory Practices (GLP) and Good Documentation Practices (GDP); maintain accurate batch records for traceability and audit readiness.

8. Quality Assurance Support: Investigate out-of-specification (OOS) results, assist in root cause analysis, and collaborate with QA to implement corrective actions (CAPAs) when microbial or identity testing limits are exceeded.

9. Regulatory Compliance: Ensure testing aligns with cGMP regulations, FDA guidelines, and internal SOPs; support internal and external audits at the Tampa site.

10. Inventory Control: Monitor and replenish lab supplies (e.g., culture media, reagents, petri dishes, FTIR consumables) to support continuous testing operations.

11. Safety Practices: Adhere to biosafety and chemical safety protocols, handle potentially biohazardous and chemical materials safely, and wear appropriate PPE per OSHA and company policies.

Minimum Qualifications

Education: Associate's or Bachelor's degree in Chemistry, Microbiology, Biology, or a related science field; Bachelor's preferred.

Experience:

12. 1-2 years of laboratory experience in chemistry, with hands-on FTIR (Fourier Transform Infrared Spectroscopy) experience required.

13. 1-2 years of experience in a microbiology lab, preferably in a GMP-regulated industry (dietary supplements, pharmaceuticals, or food); entry-level candidates with relevant training considered.

14. Demonstrated experience applying Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) within a cGMP-regulated facility.

Knowledge, Skills and Abilities:

15. Hands-on experience with FTIR spectroscopy for raw material identity testing, including spectral library use and interpretation.

16. Hands-on experience with microbial testing methods (e.g., USP <61>/<2021>, <62>/<2022>, pour plate, or membrane filtration techniques).

17. Knowledge of cGMP requirements (21 CFR Part 111) and familiarity with FDA dietary supplement regulations.

18. Proficiency in aseptic technique and working in a controlled environment (e.g., laminar flow hood).

19. Strong attention to detail for accurate data recording and compliance with SOPs, GLP, and GDP.

20. Analytical mindset for troubleshooting OOS results and interpreting chemical and microbial data.

21. Basic computer skills (e.g., Microsoft Office, LIMS software).

22. Highly organized; very effective time management skills.

23. Process management and detail-orientation.

24. Familiarity using CRMs/ERPs.

25. Availability to work weekends as required by business and production needs.

26. Willingness to work a flexible schedule, including the possibility of four 10-hour shifts (4/10) per week.

Certification or License: Not required but advantageous (e.g., HACCP, GMP training, or microbiology/chemistry-specific certifications).

Pay: $22.00 - $25.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person