No H1B/C2C/No Software QA Automation please!!!
Job Title: Quality Assurance Specialist (PHARMA - Drugs)
Work Location: Frederick, MD/Wilson, NC
W2 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.
