Associate II, Quality Control Microbiology
Biogen•Research Triangle Park, NC
•Onsite
About The Position
The Quality Control Associate II is responsible for supporting key functional, tactical, and operational aspects of the QC Microbiology group at the Biogen RTP Pharma facility. An Associate II should possess a fundamental understanding of the Biogen Quality Systems and apply it in their daily support functions. Adherence to all cGMP requirements, a basic understanding of FDA/EMA regulations, effective interactions/communication with Quality management, personal development, and support of investigations.
Requirements
- Bachelor’s Degree in biology, microbiology, chemistry or other lab-based science with 0-2 years of industry experience
- Ability to multi-task and coordinate multiple activities in parallel, demonstrate problem solving and troubleshooting skills
- Work effectively within in a team environment
Nice To Haves
- Experience with LabWare LIMS and TrackWise
- Good working knowledge of QC GMP environment
- Experience with microbiology testing: endotoxin, bioburden, environmental monitoring
Responsibilities
- Collect routine environmental monitoring (EM) samples in a clean room environment, including weekly air, particulate and surface samples.
- Colony counting and Gram staining
- Water monitoring of the WFI and USP systems and performing daily analytical and microbial testing
- Perform release and stability microbial testing, include but are not limited to: membrane filtration bioburden, endotoxin, growth promotion (GP) testing and all preparatory and post-execution activities associated with these testing in a cGMP manner.
- Perform analytical data review
- Support qualification and validation activities
- Author action excursions, CAPAs, deviations and Quality Technical Reports
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
