Quality Engineer (Biologics)
The Quality Engineer is responsible for supporting and improving the current Quality Systems at the Stratatech Facility. This position will have a wide range of tasks which may include deviation investigation, CAPA management, change management, internal/external auditing, and direct involvement and collaboration with the Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.
- Drive investigations and manage deviations and NCMRs from initiation to disposition
- Manage CAPA creation and ensure adequate effectiveness
- Perform internal and external audits of systems and suppliers
- Perform trending of Quality Systems to support FDA and Management reviews
- Improve quality culture through site initiatives
- Coaching and mentoring others in regards to QMS and Quality Culture
- Present investigations and deliver disposition recommendations
- Improve existing procedures to align with cGMP and regulatory requirements
- Interpret and properly apply all applicable regulatory requirements
- Manage supplier quality
- Perform and lead RCAs through cross functional team involvement
- Review and approval of procedures, protocols, reports, etc. as required.
- May perform additional duties as required
Department specific/Non-essential responsibilities:
- Filing and management of documentation when required
- Support Line Clearance activities and actively participate in Line level QA support
- Supporting other Quality System Functions including advising junior QA team members
- May perform any duties executed by junior QA team members once trained
Experience / Skills:
- Bachelor’s, or higher, degree in a scientific discipline biology, chemistry or engineering or
- Bachelor’s degree, or higher, and a minimum of 5 years of experience in a cGMP biologics industry
- 4+ years of experience in a cGMP Quality Assurance/Compliant environment (Biologics preferred)
- ASQ, CQA or CQE, preferred
- Effective communication, coaching/mentoring, and presenting skills
- Ability to manage change
- Project management to deliver on time results
- Leadership skills / Emotional Intelligence
- Proficient with Microsoft Office tools, especially Excel
- Technical writing
- Statistical analysis – Minitab or other software equivalent, preferred.
The Quality Engineer collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Clinical Quality, Regulatory Affairs, and Process Development. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. The position is during normal working hours M-F, but may be required to work extra hours or on weekends or holidays in order to support Manufacturing and Lot Release activities.
The Quality Engineer will mainly work in an office environment but will also be required to work in ISO Class 7 manufacturing and QC environment when providing QA support to those functional areas.