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The schedule for this position is Sunday-Wednesday 8AM-6PM
About This Role
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.
What You’ll Do
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
Who You Are
You have a passion for working in a laboratory and enjoy using your technical knowledge and data to drive key business decisions. You have an enthusiasm for learning new skills and being solutions oriented.Â
Required Skills
Bachelor’s Degree in biology, microbiology, chemistry or other lab-based science with 0-2 years of industry experienceÂ
Ability to multi-task and coordinate multiple activities in parallel, demonstrate problem solving and troubleshooting skillsÂ
Work effectively within in a team environment
Preferred Skills
Experience with LabWare LIMS and TrackWise
Good working knowledge of QC GMP environment
Experience with microbiology testing: endotoxin, bioburden, environmental monitoring
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Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.Â
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursementÂ
- 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 SignificanceÂ
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefitÂ
- 401(k) program participation with company matched contributions
- Employee stock purchase planÂ
- Tuition reimbursement of up to $10,000 per calendar yearÂ
- Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established 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 life-changing 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 Biogen.
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 E-Verify Employer in the United States.
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