Quality Assurance Specialist - DRUG (Pharma/Biotech/Medical Devices) - Frederick, MD/Wilson, NC
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Role & Company Overview
📋 Role Overview & Responsibilities
No H1B/C2C/No Software QA Automation please!!!
Job Title: Quality Assurance Specialist Work Location: Frederick, MD/Wilson, NCW2 Contract & Onsite role
We are seeking a highly motivated individual to join us as a Quality Assurance Specialist.
Required Qualifications:1-3 years experience in Quality Assurance or GMP environment (Drug Substance or Drug Product)Reviewing batch records. Must have experience in Pharmaceutical/Biotech/Medical Device Industry. Well versed with CAPA and CGMP.
Responsibilities:• Provide QA support on the floor for production• Ensure process control measures are in place and followed in product manufacturing• Receipt and disposition of incoming apheresis material.• Oversee and authorize shipment of final product• Verify and ensure timely issuance of production documents and labels• Review batch-related documentation and ensure resolution of issues to release and ship product.• Ensure that associated CAPAs are initiated and resolved, as needed.• Ensure approval and timely delivery of final product.• Ensure products are manufactured in compliance with regulatory and GMP guidelines.• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
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This position is located in Frederick, MD with potential relocation and sponsorship assistance depending on candidate qualifications.
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