Associate III Quality Control Microbiology
Associate III Quality Control Microbiology
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Salary Not Disclosed
1 Vacancy
Job Description
The schedule for this position is MF Business hours (full time onsite)
About This Role
The QC Associate III is responsible for supporting key functional tactical and operational aspects for QC Microbiology. Performs testing and all activities associated with testing. Responsibilities include but are not limited to training testing support for inprocess release and stability support for transfer qualification/ validation activities as appropriate robust and compliant cGMP documentation practices. A fundamental understanding of the Biogen Quality Systems and able to apply it in their daily support functions. Adherence to all GMP requirements effective interactions/ communication with Quality Control management and support of investigations. The Associate III should possess skills to work effectively attention to detail work with oversight from team/manager within a team framework across all business areas and levels of the organization. Able to work effectively within the group.
What Youll Do
- Performs testing of bioburden and endotoxin initiate deviations IA and A/A. Capable of performing 50% of assays within the group
- May author design protocols change control requests and Quality Technical Reports as directed
- Performs document revisions and provides technical leadership as a subject matter expert in one or more disciplines
- Provides timely review/corrections for data and documentation
- Participates in the execution of method development method qualification
- Supports maintenance of effective laboratory systems including instruments and equipment to ensure integrity of all laboratory results
- Other duties as assigned
Qualifications :
Required Skills
- Bachelors Degree in a life sciences related field
- 24 years of experience working in Quality Control in a biotech/pharmaceutical GMP environment
- Microbiology experience including expertise in bioburden and endotoxin assays
- Experience working in a drug substance and/or drug product environment
Preferred Skills
- Experience using LabWare (LIMS system)
- Method qualification experience
- Microbial identification experience
Additional Information :
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
