Quality Assurance Associate III - Shop Floor (Swing Shift)

Job Description

Swing Shift - Parenteral Facility (PF)                                                                                                
*Please note that this will be a typical Manufacturing Swing Shift position.  The employee will work a standard 2-2-3, 12-hour shift that will include every other weekend. Hours are 6 AM - 6:30 PM*

About This Role

The Assoc III, Quality Assurance will perform a wide variety of activities to ensure the quality and safety of our products at the Biogen Research Triangle (RTP) Drug Product Parenteral Facility.  Performs Quality Assurance (QA) responsibilities supporting the CGMP for Quality Operations within the Biogen Pharma Research Triangle Park (RTP) Drug Product Parenteral Facility.    This role’s primary focus will be quality oversight of the shop floor support ensuring critical steps are executed by the manufacturing associates according to the batch record and procedural requirements. Supports regulatory inspection by US FDA Agencies and other regulatory agencies.

What You'll Do:

• QA on the Floor: Rotate 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 CGMP production activities and/or release of product for further processing and/or distribution.
• Exceptions and CAPA:  Assess criticality of exceptions/investigations for product impact.  Perform thorough reviews of the investigations and provide feedback to the department owner.   Collaborate with associated departments to determine the appropriate CAPA.            
• Controlled Document Assessment and Approval:  Review documents for compliance and identify gaps in existing Quality Systems.  Initiate opportunities for process improvements.  Includes performing responsibilities associated with GXP workflows as either the QA Doc Role or Quality Unit Role. Controlled Document Assessment:  Review documents for compliance and identify gaps in existing quality systems.  Initiate 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.  Assure 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 documentation for archival.

Who You Are:

You are knowledgeable, eager to learn, ask directed questions, and challenge assumptions. Additionally, you have excellent communication/collaboration skills, logical and evidence-based thinking and can work across all levels of the organization.

Qualifications

• Bachelor’s degree preferably in a field of science or biotechnology.
• A minimum of 2 years relevant technical experience in quality oversight of a biotech or pharmaceutical manufacturing operation.
• Attention to detail, knowledge of batch record requirements and regulatory expectations.
• 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.

Preferred Qualifications

Experience in Oral Solid Dosage and/or Aseptic Manufacturing and in a Quality role.

Additional Information

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