Quality Control Tech 1 executes critical microbiological quality control testing and performs quality assurance review and disposition activities for biologics in a USDA-licensed autogenous vaccine facility. Partners with Production, Commercial Operations, Shipping/Receiving, and Diagnostics to ensure compliant, timely release or appropriate nonconformance handling of autogenous and licensed products.
Key Responsibilities
- Perform microbiological purity testing (initial and retest) per SOPs, aseptic technique, and media controls; initiate/update non-conformance reports, coordinate retests, and communicate contaminant identification outcomes.
- Environmental monitoring: schedule/execute air plates by room, manage staggered testing across days, and annotate monitoring details on applicable forms.
- Media traceability & documentation: track media types/lots and associated purity/subculture records; maintain investigation files in Quality Control.
Qualifications
- Education: BS in microbiology/biology/chemistry or related field; or Associateโs with 1โ3 years relevant lab/Quality Assurance experience.
- Experience: 1โ3+ years in Quality Control microbiology or Quality Assurance in biologics/pharma, vaccines, or regulated manufacturing; non-conformance reports, deviations, and retest workflows; familiarity with certificate of analysis issuance, product disposition, and testing procedures.
- Technical skills: aseptic technique; environmental monitoring; purity testing and subculture; data review/documentation control; ERP and QMS platform experience.
- Skills: detailed records; high attention to detail and quality; strong team collaboration; time management and ability to handle multiple priorities; proficient with email/phone/office equipment.
Preferred/Helpful
- Familiarity with USDA CVB processes and regulatory requirements for autogenous vaccine production.
- Familiarity with CAPA and effectiveness check processes.
Working Conditions/Physical Requirements
- Laboratory environment with PPE; extended standing/bench work; occasional lifting up to 25 lbs; work across controlled areas and coolers/incubators; occasional off-shift/weekend support.
- Required to lift/carry 21โ50 lbs; bend constantly; stand/talk/hear constantly; specific vision abilities (adjust focus, close/distance, depth, peripheral).
Benefits & Application Instructions
- Hourly rate: $22.00โ$25.00 (range provided).
- Work schedule: MondayโFriday (standard work hours).
- To learn more about benefits: Phibro Benefits.