Associate II, Quality Control Microbiology

Associate II, Quality Control Microbiology

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.

Required Skills

• 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

• 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

• Additional Information

• 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.

• 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.

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 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