Quality Specialist Engineer
Core
Provide expert oversight and guidance on GMP operations, investigations, change controls, and compliance activities within maintenance and engineering functions.
Role type
Quality Specialist Engineer (GMP Compliance)
Builds
Engineering investigations, change controls, deviation reports, and SOPs for a biotechnology client.
Domain
Life Sciences / Biotechnology / GMP Compliance
Required skills
GMP requirements knowledge, engineering investigation analysis, change control management, regulatory compliance auditing, corrective and preventive action (CAPA) implementation, technical documentation review
Preferred skills
Coaching and training delivery, cross-functional collaboration, problem-solving with data, stakeholder influence
Technologies
GMP systems, engineering documentation tools, quality management software
Responsibilities
Review and approve engineering documentation including change controls and investigation reports; Identify and escalate quality or compliance issues; Ensure engineering activities adhere to GMP requirements and safety policies; Coach Engineering personnel on GMP compliance and investigation processes; Collaborate with cross-functional teams to drive continuous improvement.
Seniority
Mid-level, hands-on IC
