QC Microbiologist
QC Microbiologist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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:
- Train on assigned SOPs and perform OJT/Qualification as applicable
- Perform environmental monitoring (EM) which requires gowning qualification routine EM sampling plate incubation/enumeration
- Support method transfers and method qualification/suitability
- Perform required onsite microbiology compendial and raw material testing which includes but not limited to: Bioburden Endotoxin ID Growth Promotion pH Osmolality and Appearance.
- Participate in laboratory investigations deviation investigations.
- Identify areas for continuous improvement and complete document revisions.
- Author and Lead Technical Protocols and Technical Reports
- Data entry scanning filing and trending
- Order QC supplies to support testing
- Initiate Work Order as required for laboratory equipment
- Represent the department in cross functional meetings and projects
Qualifications :
Basic Minimum Responsibilities:
- BS or MS degree in Biology/Microbiology required
- Minimum 5 years of related experience in the Biotechnology/Medical Device/ Pharmaceutical manufacturing laboratory industry
- Experience working in a GMP environment is required
- Must have hands on experience performing Microbiological testing such as: growth promotion endotoxin and microbial limits/bioburden testing.
- Hands on experience sampling in Clean Room environments and aseptic technique
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:
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Yearly goalbased bonus & eligibility for meritbased increase
Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
