QC Microbiologist

Lief Labs is a premier formulation, product development, and manufacturing partner for leading dietary supplement brands. Our world‑class R&D and Product Development teams create innovative, great‑tasting formulations, while our state‑of‑the‑art cGMP manufacturing facility delivers scalable, turnkey solutions that help entrepreneurial companies build and grow successful brands.

We are seeking a QC Microbiologist to join our Quality Control team in Valencia, California. This is an exciting opportunity for a microbiology professional who thrives in a GMP‑regulated environment and is passionate about product safety, quality, compliance, and continuous improvement.

In this role, you will serve as a key microbiological resource supporting the testing and release of raw materials, packaging components, in‑process materials, and finished products while helping maintain the highest standards of quality and regulatory compliance.

• 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.

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

• Minimum 5 years of experience in a GMP‑regulated microbiology laboratory.
• Experience with in 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 61, 62, 2021, and 2022.
• 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.
• Strong analytical, troubleshooting, and problem‑solving abilities.
• Excellent documentation and technical writing skills.
• Except…