QC Microbiologist

About the role

Lief Labs is a premier formulation, product development, and manufacturing partner for leading dietary supplement brands. We are seeking a QC Microbiologist to join our Quality Control team in Valencia, California.

Responsibilities

• Perform microbiological testing of raw materials, packaging components, in-process samples, finished products, and environmental monitoring samples.
• Conduct testing for APC, Yeast & Mold, Coliforms, E. coli, Salmonella, Staphylococcus aureus, and other applicable microorganisms.
• Review and interpret laboratory results to ensure compliance with FDA, USP, and internal specifications.
• Maintain accurate, complete, and auditable laboratory documentation in accordance with GMP, GLP, and data integrity requirements.
• Execute environmental monitoring programs, including air, surface, water, and personnel monitoring.
• Support cleaning validation, sanitization verification, equipment qualification, and contamination control initiatives.
• Conduct ATP and microbiological swabbing activities and evaluate results.
• Assist in assessing microbiological risks related to new equipment, facility modifications, and process changes.
• Lead or support investigations involving out-of-specification (OOS), atypical, or nonconforming laboratory results.
• Perform root cause analysis and support corrective and preventive actions (CAPA).
• Participate in customer complaint investigations involving microbiological concerns.
• Author and revise SOPs, validation protocols, test methods, technical reports, and controlled quality documents.
• Partner with Quality Assurance, Production, Sanitation, R&D, and Operations teams to support product quality and safety initiatives.
• Provide microbiological expertise during audits, inspections, and quality investigations.
• Assist with microbiology, sanitation, and GMP training for laboratory and production personnel.
• Support internal audits, supplier audits, and client or regulatory inspections.

Requirements

• Minimum 5 years of experience in a GMP-regulated microbiology laboratory.
• Experience within dietary supplements, pharmaceuticals, food manufacturing, or a related regulated industry preferred.
• Hands-on experience performing microbiological testing and environmental monitoring activities.
• Experience supporting audits and inspections in a regulated environment.
• Strong understanding of USP microbiological methods including USP , , , and .
• Knowledge of FDA regulations, including 21 CFR Part 111 and 21 CFR Part 117.
• Experience with method validation, investigations, CAPA, and technical report writing.
• Familiarity with LIMS and electronic laboratory systems are preferred.
• Working knowledge of cGMP, GLP, GDP, and laboratory safety requirements.

Qualifications

• Bachelor's degree in Microbiology or a related scientific discipline.

Skills & Competencies

• Strong analytical, troubleshooting, and problem-solving abilities.
• Excellent documentation and technical writing skills.
• Exceptional attention to detail and organizational skills.
• Ability to communicate scientific information effectively to cross-functional teams.
• Self-motivated, adaptable, and able to manage multiple priorities in a fast-paced manufacturing environment.
• Proficiency with Microsoft Office applications.

Physical Requirements

• Regular standing, walking, bending, kneeling, crouching, reaching, and lifting throughout the workday.
• Frequently lift and move items up to 10 pounds and occasionally up to 20 pounds.
• Ability to perform laboratory work requires close attention to detail and visual accuracy.

Compensation & Benefits

Salary Range: $74,000 - $88,000 annually
Benefits Include:
- Medical, Dental, and Vision Insurance
- 401(k) with Company Participation
- Life Insurance
- Wellness Benefits
- Education Reimbursement Program
- Paid Time Off (PTO)

Why Join Lief Labs?

If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request accommodation, contact the Lief Human Resources department.

Equal Opportunity Employer

Lief is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.