Quality Engineer (Biologics)
Summary
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.
Principal Responsibilities
- 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
Minimum Requirements
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
- Self-motivated
- Project management to deliver on time results
- Leadership skills / Emotional Intelligence
Competencies:
- Proficient with Microsoft Office tools, especially Excel
- Technical writing
- Statistical analysis - Minitab or other software equivalent, preferred.
Organizational Relationship/Scope:
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.
Working Conditions:
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.
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