Associate II, Quality Control Microbiology

About This Role

The Quality Control Associate II supports key functional, tactical, and operational aspects of the QC Microbiology group at the Biogen RTP Pharma facility. This role requires a fundamental understanding of Biogen Quality Systems and their application in daily support functions, adherence to cGMP requirements, basic knowledge of FDA/EMA regulations, effective communication with Quality management, personal development, and support of investigations.

Responsibilities

• Collect routine environmental monitoring (EM) samples in a clean room environment, including weekly air, particulate, and surface samples.
• Perform colony counting and Gram staining.
• Conduct water monitoring of the WFI and USP systems and perform daily analytical and microbial testing.
• Perform release and stability microbial testing, including but not limited to: membrane filtration bioburden, endotoxin, growth promotion (GP) testing, and all preparatory and post-execution activities associated with these tests in a cGMP manner.
• Perform analytical data review.
• Support qualification and validation activities.
• Author action excursions, CAPAs, deviations, and Quality Technical Reports.

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, demonstrating problem-solving and troubleshooting skills.
• Work effectively within 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.

Job Level: Entry Level

Schedule

Sunday-Wednesday, 8AM-6PM

Pay

The base compensation range for this role is $57,000.00 - $74,000.00. 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.

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.

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.