About This Role

The Quality Assurance Associate II will perform a wide variety of activities to ensure the quality and safety of our products.  Primarily, this role provides on-the-floor quality oversight of GMP manufacturing activities.  Those activities include review of batch record pages, logbooks, equipment reports, and directly collaborating with Manufacturing Associates to assist with problem resolution. Additionally, activities include, but not limited to, the following:  Data and Documentation Review and Analysis, Batch Record Review, and Deviations.

*Please note that this is a typical Manufacturing Swing Shift position (6 AM to 6 PM).  The employee will be working a standard 2,2,3 12-hour shift that must work every other weekend. 

What You’ll Do

• Provide quality oversight during batch manufacturing
• Primary point of contact for issues that need immediate corrective action plans, product impact assessments and decisions with respect to batch discrepancies
• Responsible for compliance monitoring of the manufacturing area
• Reviews documents (e.g., production records, test methods, raw data, and certificates of analysis) for compliance and determines acceptability for use in GMP production activities and/or release of product for further processing and/or distribution
• Assesses criticality of exceptions/investigations for product impact
• Performs thorough reviews of the investigations and provides feedback to the department owner
• Collaborates with associated departments to determine the appropriate CAPA
• Responsible for controlling master production records and issuing working copies of these records according to the production scheduled
• Records are printed and verified to be accurate prior to issuance
• Assures compliance against applicable PRCD’s providing QA controlled document creation, revision, retirement, and issuance requirements

Who You Are  

You enjoy drug production activities with a passion to build strong collaborative partnerships with cross functional teams.  You have an enthusiasm for learning new technological skills and being solutions oriented. 

• Minimum BA/BS with 1-2 years of relevant industry experience required.
• Attention to detail
• Good organizational skills
• Developing ability to multi-task and coordinate multiple activities in parallel with a sense of urgency
• Ability to prioritize, plan and schedule
• Strong oral and written communication skills
• Investigative decision-making skills
• Problem identification and resolution skills
• Flexibility supporting schedule and manufacturing activities

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

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 E-Verify Employer in the United States.