About This Role

As our QA Associate III you will be perform responsibilities supporting the cGMP Quality Operations within the Biogen Pharma Research Triangle Park (RTP900) Drug Product Parenteral Facility. This role primary focus will be quality oversight of the shop floor support ensuring critical steps are executed according to the batch record and procedural requirements. Perform exceptions review and approval. Respond to operational needs requiring QA assessment and approval. Provides guidance regarding regulatory compliance, technical expertise, independent assessment, and consultation to the Parenteral Fill Finish Manufacturing, Compounding and Packaging, QC, and Engineering departments. You will also perform a wide variety of activities to ensure the quality and safety of our products. Activities include, but not limited to, the following: Data and Documentation Review and Analysis, Exceptions/Investigations and CAPA, Technology Transfer and Inspection Readiness and Participation, Controlled Document Assessment, Document Management, Training, and Data Trending. Supports regulatory inspection by US FDA and other regulatory bodies. It is expected that this role will report directly into the Senior Supervisor, QA.

What You’ll Do

• QA on the Floor: Rotates with other QA colleagues to 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 as well as leads several area self-inspections. Assist with batch disposition through review of 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.
• Exceptions, Complaints and CAPA: 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.
• QA Document Change Control and Production Record Issuance: 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 procedures providing QA controlled document creation, revision, retirement, and issuance requirements. Controlled Document Assessment: Reviews documents for compliance and identifies gaps in existing quality systems. Initiates opportunities for process improvements
• Production BPR Issuance: Responsible for issuing effective copies of batch records according to the production schedule. Records are printed and verified to be accurate prior to issuance. Assures compliance verification per PRCD’s providing QA controlled document creation, revision, retirement, and issuance requirements.
• Complete QA Review Logbook and Room Cleaning documentation and prepare pare documentation for archival.

Who You Are

You have solid knowledge and experience in QA in pharmaceutical or biotech manufacturing environment. As a person have the ability to influence audience and demonstrate cross functional leadership.

• Bachelor’s Degree in a scientific discipline.
• 3-4 years related pharmaceutical/biotech experience; preferably with experience in oral solid dosage and/or aseptic manufacturing and in a quality role.
• Demonstrated understanding and application of CGMP’s, relevant laws, guidance’s, directives and current industry practices.
• 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.