We are seeking a highly motivated individual to join us as a QC Microbiologist in our new commercial cell therapy production center located in Frederick MD. You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. This position provides Quality Control microbiological testing for commercial manufactured products responsible for product testing utility testing and environmental monitoring.
Responsibilities:
- Performs environmental and/or utility monitoring and sampling as a primary function.
- Performs routine and nonroutine inspection of media fill samples (AOQ/APV) collection and/or testing of media final product validationrelated and critical utility samples according to SOPs.
- Receives quarantines and stores purchased microbiological media pending laboratory release.
- Monitors bio hazardous waste and coordinates its removal with qualified safety personnel.
- Participates in validation and commercial/developmental manufacturing activities.
- Reviews and issues Environmental Notifications based on raw data and validated electronic data acquisition systems.
- Represents QC for area of specialization in site meetings.
- Supports testing of solid oral dosage packaging component testing raw material and sterile product testing.
- Troubleshoots standard instrumentation/test methods.
- Performs activities in support of final product release testing (e.g. tests applicable for endotoxin sterility and particle isolation) and raw material testing (e.g. media growth promotion) where required.
- Performs activities in support of environmental monitoring including surface viable air nonviable air and personnel monitoring.
- Performs activities in support of bioburden testing of water and product; and viable/nonviable particles moisture testing of compressed gases/air
Qualifications :
Ideal Candidate Would Possess:
- Prior experience in the biopharmaceutical or pharmaceutical industry
- Prior lab experience
- Basic Knowledge of current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) daily.
- Basic Knowledge of general Microbiology techniques such as gram staining aseptic technique and plate streaking technique.
- Knowledge of USP and other regulatory requirements.
- Knowledge of HPLC and UPLC systems.
- Proficiency in Microsoft Office applications.
- Ability to work effectively in a team environment.
- Strong verbal written and interpersonal communication skills are required.
- MODAL/LIMS proficiency.
- Technical training on environmental monitoring of facility and utility systems.
Minimum Qualifications:
- 2 years of relevant experience and a High School diploma or BS degree or degree in a related field
Additional Information :
The position is fulltime second shift SunWed from 7am6pm. Candidates must be flexible to adapt to schedule changes requiring shift changes and/or weekend work and overtime may be required as needed. Candidates living within a commutable distance of Frederick MD 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 increases
Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global awardwinning insourcing solution that places our people at our clients sites dedicated to running and managing laboratory services while eliminating headcount coemployment and projectmanagement worries.
We infuse our 55year 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 is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime