Responsibilities: for the QA Document Control Manager include: • Manage daily activities of the Document Control team. • Administer and maintain the eDMS system (MasterControl preferred). • Review and approve SOPs, protocols, forms, and GMP documentation. • Support regulatory audits and FDA inspections. • Maintain training records and document control processes. • Partner with cross-functional teams to ensure compliance. • Identify and implement process improvements. Required Qualifications for the QA Document Control Manager include: • Bachelor's degree in a scientific discipline or equivalent experience. • 8+ years of experience in a GMP-regulated environment. • Experience working in an FDA-regulated environment. • Strong knowledge of cGMP regulations and quality systems. • Experience with eDMS platforms; MasterControl preferred. • Previous leadership or people management experience. • Strong technical writing and documentation skills. Qualifications: for the QA Document Control Manager include: • Bachelor's degree in a scientific discipline or equivalent experience. • 8+ years of experience in a GMP-regulated environment. • Experience working in an FDA-regulated environment. • Strong knowledge of cGMP regulations and quality systems. • Experience with eDMS platforms; MasterControl preferred. • Previous leadership or people management experience. • Strong technical writing and documentation skills.
| Location | Elkridge, MD |
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