Sr. Associate I, Quality Assurance (Quality Engineering)

Biogen Idec - Research Triangle Park, NC

Full-time

Research Triangle Park, NC

Chemical Manufacturing

About the position

The Quality Engineering (QE) Senior Associate I is responsible for the oversight of key functional, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The QE Senior Associate I will perform all duties in a manner consistent with site and corporate policies, cGMPs, safety, environmental and human resources policies and procedures and be proficient in their understanding of the Biogen Quality Systems and apply that knowledge in coaching and continuous improvement for all Quality System cross-functionally.

Responsibilities

• Review and approval of facility, utility, equipment, analytical instruments and automation lifecycle documentation including; User Requirements, Specifications, Drawings, Risk Assessments, Test Protocols, Deviations, Reports, Procedures and Periodic Reviews.
• Review and approval of changes affecting validated analytical instruments, manufacturing processes, equipment, facility, utility, automation systems, material/components, and business processes associated with IT GMP computerized systems.
• Provide cGMP guidance and quality risk management support of manufacturing on the floor issues with equipment or systems, including review and approval of deviations and Corrective/Preventive Actions (CAPAs).
• Support the site changeover program by providing oversight of multi-product equipment inspection and release including the review of changeover documentation, sampling, elastomer replacement, carry-over calculations, engineering configuration, summary reports and equipment release.
• Support site capital projects by providing GMP guidance, risk management input and quality oversight during shut down planning, release and other major equipment/facility improvements.
• Review and approval of GMP Preventive/Corrective maintenance work as applicable.
• Lead investigations and CAPAs including driving Continuous Improvement initiatives.
• Proactive identification and resolution of both technical and compliance issues/gaps.
• Develop and implement aspects of various Quality Systems/System Improvements.

Requirements

• Bachelor's Degree in Engineering or related Life Science or Technical discipline with minimum 4 years of relevant industry and quality experience.
• Thorough knowledge of FDA/EMA regulations including Current Good Manufacturing Practices (cGMPs) and International Council for Harmonization (ICH) guidelines.
• Thorough Knowledge of Quality Engineering Systems (Facilities, Utilities, Maintenance, Engineering, Validation, and Automation).
• Experience in investigations, change controls, and CAPAs processes system knowledge.
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to effectively communicate and collaborate with technical and senior management staff.
• Experience in managing multiple, competing priorities in a fast-paced environment and dealing with ambiguity.
• Demonstrated troubleshooting and strong problem-solving skills and the ability to develop innovative/creative solutions to issues of moderate or high complexity.

Nice-to-haves

• Thorough knowledge and/or previous experience with cGMP Drug Substance or Drug Product Manufacturing environments.
• Experience in Engineering and/or Validation (Equipment, Cleaning, Computerized Systems).
• Ability to evaluate compliance issues and interact with regulatory inspectors.
• Experience in QA oversight of manufacturing, analytical and engineering activities.
• General knowledge of Project Management competencies obtained through relevant PM training or experience.
• General knowledge of industry best practices including ISPE Baseline Guide 5, GAMP5 and ASTM E-2500.