Senior QC Microbiologist â SME
Senior QC Microbiologist â SME
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Job Description
Eurofins PSS is hiring a Senior QC Microbiologist SME to support pharmaceutical quality control operations at a client site. This is a hands-on role for someone with deep expertise in microbiology who can work independently and serve as the go-to resource for microbiology-related questions and processes.
While this is not a leadership position there is potential to grow into a leadership role over time.
What Youll Do
- Perform sterility endotoxin pH and osmolality testing on raw materials and drug products.
- Conduct gram stains growth promotion testing and cell culture work.
- Lead aseptic process media fills and related testing (e.g. visual inspection).
- Carry out environmental monitoring (air surfaces personnel particulates) in cleanrooms.
- Keep lab equipment clean and maintained; ensure documentation is complete and compliant.
- Write and update SOPs change controls and qualification protocols.
- Investigate out-of-specification (OOS) results and non-conformances; identify root causes and implement corrective actions.
- Perform internal audits and walk-throughs to ensure compliance.
- Collaborate with Manufacturing QA and Facilities teams to meet production goals.
- Train other lab staff as needed.
What You Need to Know
- Sterility and endotoxin testing
- USP standards
- Growth promotion and gram staining
- Environmental monitoring in pharma settings
- Aseptic process media fills
- cGMP and Good Documentation Practices
Qualifications :
- Bachelors degree in a scientific field (e.g. Microbiology Biology)
- At least 4 years of microbiology experience in a GMP pharmaceutical or biologics environment
- Strong experience with BacT rapid sterility assay endotoxin testing growth promotion and aseptic processing
- Experience with mammalian cell culture and aseptic manufacturing
- Familiarity with lab equipment like microscopes pH meters and incubators
- Excellent communication skills and ability to work independently
- Willingness to work occasional off-shifts and weekends
- Ability to train and support other team members
Additional Information :
What to Expect in the Hiring Process:
- 10-15 Minute Phone Interview with Region Recruiter
- 45-60 Minute Virtual Interview with Manager and/or Group Leader
Additional Details:
Position is Full Time Monday Friday First Shift with support outside of standard hours. Candidates currently living within a commutable distance of Exton PA are encouraged to apply.
Excellent full-time benefits include:
- comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holiday
- Yearly goal-based bonus & eligibility for merit-based increases
Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global award-winning insourcing solution that places our people at our clients sites dedicated to running and managing laboratory services while eliminating headcount co-employment and project-management worries.
We infuse our 55-year track record of scientific and laboratory operations expertise as well as HR and a great place to work best practices to recruit hire train and manage highly qualified scientists to perform laboratory services using our clients quality systems and equipment.
To learn more about Eurofins Lancaster Laboratories please explore our website .
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
