QA Sterility Assurance Specialist
1 week ago
Work Schedule 12 hr shift/days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Position Summary This is an outstanding opportunity to join our team as a QA Sterility Assurance Specialist, where your expertise will ensure the flawless production of injectable sterile pharmaceuticals. You will strictly adhere to cGMP norms and regulatory procedures, playing a meaningful role in our Global Sterility Assurance Group. As a Subject Matter Expert, you will provide mentorship and ensure our site’s contamination control strategy is successfully implemented. Responsibilities Guarantee that safety remains our top priority and is lived throughout the organization. Develop and maintain the Contamination Control Strategy (CCS) for the site, ensuring compliance with regulations. Coordinate maintenance activities within the sterility assurance department to minimize environmental contamination and product risk. Collaborate with the investigation team to manage quality events impacting sterility and evaluate deviations and complaints. Review and approve major deviations and corrective/preventive actions related to sterility assurance. Contribute to the development and revision of SOPs impacting sterility assurance and evaluate necessary changes. Analyze data from Environmental Monitoring (EM) to identify trends and establish corrective measures. Work with other teams to improve processes and systems, growing the Sterility Assurance Level (SAL). Review and implement surveillance plans for aseptic techniques, ensuring any gaps are addressed. Support engineering projects, particularly in the design phase, to ensure sterility assurance. Prepare and revise risk assessments in compliance with Annex 1. Minimum Requirements/Qualifications Education: Bachelor’s Degree in Life Sciences, Chemical/Biochemical Engineering, or a related Pharma Scientific Area with equivalent experience considered Experience: 1 to 2 years of experience in a Quality department within a sterile production manufacturing site Proficiencies: Knowledge of cGMP environments Technical expertise in microbiology, Endotoxin, Bioburden, Sterility, and associated testing protocols Compliance with local, state, and federal regulations (e.g., NMPA, HSA, FDA)Effective communication skills across all organizational levels Ability to work cross-functionally with Quality Control, Operations, and Biologics teams Participation in Health Agency/internal audits Technical skills: Strong background in sterility assurance, aseptic techniques, manufacturing of sterile injectables and Contamination Control Strategy (CCS). Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. #J-18808-Ljbffr
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