Quality Control Microbiologist
Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
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 product, 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 non-routine inspection of media fill samples (AOQ/APV), collection and/or testing of media, final product, validation-related, 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, non-viable air and personnel monitoring.
- Performs activities in support of bioburden testing of water and product; and viable/non-viable particles, moisture testing of compressed gases/air
Qualifications
Requirements:
- BS degree, or degree in related field
Preferred Requirements:
- Prior experience in biopharmaceutical or pharmaceutical industry
- Prior lab experience
- Basic Knowledge of current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis.
- 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 system.
Additional information
Position is full-time, first shift Monday - Friday. Candidates must be flexible to adapt to schedule changes requiring shift changes and/or weekend work, and overtime may be required as needed. Candidates currently living within a commutable distance of Frederick, MD are encouraged to apply.
- 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
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.