Specialist - Manufacturing - Engineering Support

Role: Quality Documentation Specialist supporting GMP manufacturing processes in biopharma. Objectives: develop, review, and update technical documents such as SOPs, work instructions, protocols, and reports; manage quality records including deviations, CAPAs, and change controls; support process improvements and troubleshooting. Responsibilities: collaborate cross-functionally to ensure documentation accuracy, facilitate document changes, and support GMP standards; liaise with Quality Assurance for compliance; support training and technical support for manufacturing teams; track activities related to change control implementation. Qualifications: Doctorate or Master’s degree with 2+ years, Bachelor’s with 4+ years, Associate’s with 8+ years, or high school diploma with 10+ years experience in pharmaceutical, biotech, or medical device manufacturing. Preferred skills include experience in GMP environments, technical writing, device assembly, and troubleshooting; ability to translate technical info for operators; creative communication skills. High-Value: GMP manufacturing, biopharma (biologics/therapeutic areas not specified), process documentation, change control, deviations, CAPA, troubleshooting, technical writing. Work Setup: Not specified, but likely collaborative manufacturing environment.