Primary Duties:
The Quality Control Microbiologist will be primarily responsible for sampling and testing of clean utilities and clean rooms to support the commissioning qualification and startup of a new manufacturing facility the Gene Therapy Innovation Center (GTIC). Other responsibilities will include conducting method qualification method suitability testing validation and routine testing of microbiological and compendial assays in compliance with all applicable quality systems and current cGMPs within the Quality Control Operations organization. They will support the departmental goals and contribute to general operations of the microbiology laboratory. This role will contribute to the development and implementation of new programs that govern general and microbiology specific laboratory practices participate in OOS and Alert / Action Investigations generate deviation documentation and trend reports and assist with audit preparation and participation. They will author review and revise SOPs reports technical documents and attend crossfunctional team meetings as a QC Microbiology representative.
In addition the Quality Control Microbiologist will perform cGMP testing to support microbiological testing of raw materials inprocess finished product and stability samples. Testing will include but is not limited to: environmental monitoring and plate reads gowning qualification endotoxin bioburden. They will ensure compliance with current regulatory requirements (USP EU ISO ICH and FDA guidance) good documentation practices (cGDP) and industry best practices for manufacturing (cGMP).
Job Description:
Qualifications :
Basic Minimum Responsibilities:
Additional Information :
Position is Full Time MondayFriday 8am5pm with overtime as needed. Candidates currently living within a commutable distance to Philadelphia PA are encouraged to apply.
What we offer:
Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime
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