Senior Microbiologist
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Job Location:
Raleigh, WV - USA
Monthly Salary:
Not Disclosed
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Senior Microbiologist
Location: Raleigh NC
Duration: Long-Term
Overview:
Seeking a Senior Microbiologist to support a QC Microbiology lab involved in sterile injectable manufacturing. This role handles complex microbiological testing environmental monitoring (EM) deviations OOS/OOT investigations CAPAs and daily QC lab operations in a fast-paced FDA-regulated environment.
Key Responsibilities
- Perform and oversee microbiological testing and EM activities in compliance with cGMP USP and FDA standards.
- Lead deviation investigations OOS/OOT reviews and CAPA development.
- Maintain QC data metrics and tracking spreadsheets/databases.
- Manage lab inventory ordering and material issues.
- Serve as SME; train junior microbiologists in aseptic techniques EM and microbiological methods.
- Support qualification and maintenance of lab equipment; troubleshoot issues and ensure GLP compliance.
- Review GMP data trend results and identify risks or performance issues.
- Participate in method transfers validations and equipment IQ/OQ/PQ activities.
- Support audits documentation updates SOP improvements and continuous improvement initiatives.
- Conduct data analysis and prepare reports EM trend summaries and investigation documentation.
Qualifications
- Strong knowledge of microbiology in a pharmaceutical QC environment.
- Experience with EM programs sterile manufacturing and cGMP compliance.
- Skilled in deviation investigations CAPA OOS/OOT handling and root-cause analysis.
- Ability to train staff manage lab operations and oversee equipment qualification.
- Strong documentation communication and problem-solving skills.
Key Skills
- Laboratory Experience
- Virology
- FDA Regulations
- Infusion Experience
- Laboratory Procedures
- PCR
- Biotechnology
- Microbiology
- Quality Control
- GLP
- cGMP
- QA/QC
