QC Technician – Microbiology Lab
Pacer Group · San Diego, CA
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The preferred schedule is Monday through Friday, with a start time of 6:30 AM or later to allow overlap with the rest of the team.Job SummaryReporting to the Microbiology Lab Supervisor, the QC Technician will support microbiology laboratory activities, with a primary focus on sterility assurance and microbiological testing. The technician will perform testing according to established work instructions, procedures, protocols, and standards while maintaining accurate records and ensuring compliance with internal quality procedures and applicable regulatory requirements.The ideal candidate will have 5+ years of experience in a sterility assurance microbiology laboratory, particularly with bioburden testing, Sterility Dose Audits, and bacterial endotoxin testing.Key Responsibilities
- Perform sterility testing, including Sterility Dose Audits (SDA) and Biological Indicator (BI) testing, where applicable.
- Conduct non-sterile bioburden and particulate testing while maintaining a sterile field.
- Perform Bacterial Endotoxins Testing (BET/LAL) and associated validations or revalidations.
- Prepare microbiological media, perform quality checks, and sterilize testing equipment.
- Conduct environmental monitoring of laboratory and controlled areas.
- Collect, analyze, and trend microbiology testing data.
- Review Quality Management System (QMS) documents and procedures before release or updates.
- Identify compliance issues and ensure adherence to internal procedures and external standards.
- Notify and work closely with management regarding Out-of-Specification (OOS) results.
- Support training initiatives and train new associates.
- Ensure testing turnaround times are met.
- Assist with the design and implementation of new laboratory equipment, as needed.
- Maintain accurate documentation and support laboratory quality activities.Required Qualifications
- Bachelor's degree in Microbiology, Biology, Biochemistry, or a related scientific discipline, or equivalent experience.
- Minimum 5 years of relevant experience in a microbiology or sterility assurance laboratory.
- Hands-on experience performing microbiological laboratory testing.
- Understanding of ISO 13485, 21 CFR 820, and related quality standards.
- Strong attention to detail and accurate documentation skills.
- Ability to follow established laboratory procedures and protocols.Preferred Technical Skills
- Sterility Assurance Testing
- Bioburden Testing
- Sterility Dose Audits (SDA)
- Biological Indicator (BI) Testing
- Bacterial Endotoxins Testing (BET/LAL)
- Sterility Testing
- Growth Promotion Testing
- Particulate Testing
- Environmental Monitoring
- OOS Investigations
- LAL Testing Validation and Revalidation
- Quality Management System (QMS) DocumentationPreferred Soft Skills
- Team player
- Quick learner
- Excellent communication skills
- Strong attention to detail
- Ability to work effectively in a regulated laboratory environmentEEOC ComplianceWe are an equal opportunity employer, and all qualified applicants will receive consideration for employment.DISCLAIMERAI Usage Policy: Pacer Group uses AI to assist in screening applications. Final hiring decisions are made by human recruiters based on qualifications and experience.