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.