What are the responsibilities and job description for the Microbiologist - Sterile Fill & Finish position at PCI Pharma Services?
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The Sterile Fill and Finish (SFF) QC Microbiologist is responsible for conducting sampling and testing of production environments, and/or facility clean utilities, as per approved procedures. Performs Lab work and other tasks as assigned by management. The SFF QC Microbiologist will support maintaining the SFF cleanroom environments for the SFF manufacturing areas. The role will support the sampling and Environmental Monitoring (EM) of the other clinical packaging cleanroom areas at the San Diego facility. This job has no supervisory responsibilities.
- The SFF QC Microbiologist will perform routine Environmental Monitoring of the classified clean rooms and monitor classified clean rooms during manufacturing operations
- Sample and test any identified production water such as USP Purified Water systems or procured purified water. This would also include the analysis of EM/utility media plates for all environmental and utility testing with minimal supervision. This would include generation for regular EM/utility microbiological trend reports.
- Support the performance of media fills including the management and visual inspection of incubated media fill vials and plates.
- Training of staff in routine processes such as aseptic techniques and sterility assurance principles.
- Ability to author production and technical documents such as protocols/experiments/SOPs.
- Provides support and analysis for the resolution of deviations, investigations, process issues, and performs required risk assessments. Be an SME for various processes.
- Support the preparation of Change Controls and CAPA's.
- Participate in the review of processes to achieve cost effectiveness and improved product quality. Develop process knowledge.
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.