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- review and approval for batch records, auxiliary forms, deviations, CAPAs, change requests, validation protocols, etc.
- GMP walkthrough inspections to ensure compliance with cGMPs and regulatory requirements.
- participates in site inspections/audits by fulfilling requests for information.
- approve SOPs and other instructional documents for shop floor.
- training to various groups as needed and ensures compliance with departmental procedures.
- Minimum Requirement: Bachelors degree required - concentration in Chemistry, Chemical Engineering, Pharmacy, Biology, Microbiology, or equivalent preferred.
- Experience and Skills: Experience in the pharmaceutical industry with knowledge of Quality Systems, Quality Assurance, and Quality Control including regulatory requirements. Exposure to SAP and project management.
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Quality Assurance Specialist - Elkton, United States - The Spear Group
Description
The Spear Group Specialist Quality Assurance, with guidance from the Quality Assurance Leader, ensures product/process quality through the review of GMP documents, facilities and processes and performs activities to ensure the reliable release of quality products to the marketplace. He/she is responsible for ensuring adherence to Divisional, Company and Site policy, procedures, and guidelines.
The Quality Assurance Specialist position requires strong collaboration, communication, and decision making attributes. Key elements of this position are also detailed process and facility knowledge and frequent shop floor presence.
PRIMARY ACTIVITIES:
Position Qualifications:
Salary: Competitive Salary offerings
Benefits: Paid Leave, 401-K, Group Medical, Dental, Vision, Life, AD&D, etc.
