REQUIRED SKILLS

• Bachelor’s degree required, preferred in a science discipline
• Minimum 4 years of experience working in a GMP quality environment within biotech/pharmaceutical industry
• Experience in drug product batch record review and disposition
• Experience with deviations varying in complexity
• Strong knowledge in FDA/EMA regulations and compliance
• Strong organizational skills; ability to multi-task
• Investigative mindset and solid decision making skills
• Critical thinking skills and has a questioning attitude

PREFERRED SKILLS

• Experience in aseptic fill/finish manufacturing operation
• Microbiology experience
• Experience working in a parenteral filling environment
• Experience in Oral Solid Dose or Oligonucleotide manufacturing environmentExperience supporting audits and/or investigations
• 
  Job Level: Professional

A Sr. Associate I, Quality Assurance is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral facility. Specifically, this role will have primary quality oversight of the following activities: (1) Batch Records, (2) Exceptions/Investigations and (3) QA Controlled Documentation:

What You ’ll Do

• Batch Record Review/Product Disposition : Review 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 : Assess criticality of exceptions/investigations for product impact. Perform thorough reviews of the investigations and provide feedback to the department owner. Supports complaint investigations with the ability to analyze the complaint defect and determine potential areas within the process that may have attributed to the defect. Collaborates with associated departments to determine the appropriate
• QA Controlled Documentation : Review and approve content for controlled documents within the quality system to ensure compliance with procedural requirements and standards. Additionally, technical reports issued requiring a Quality review are in scope of this role.

Who You Are
You are task-driven and focused; willing to proactively action to resolve, remediate and/or improve. You are collaborative and capable of being both agile and customer-focused.