Quality Assurance Specialist
3 days ago
We are seeking a highly motivated individual to join our team as a Quality Assurance Specialist. In this role, you will support the activities of the Quality Assurance department at our manufacturing site in Frederick, MD.
Key Responsibilities:
- Provide QA support on the production floor
- 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
- Gather and report metrics to measure performance
- Identify continuous improvement actions
- Ensure timely resolution and escalation of issues
- Ensure all product-related Deviations are initiated, investigated and resolved
- Ensure that associated CAPAs are initiated and resolved, as needed
- Perform lot closure activities
- Ensure approval and timely delivery of final product
- Ensure products are manufactured in compliance with regulatory and GMP guidelines
Requirements:
- BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) OR
- Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR
- High School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product)
Preferred Qualifications:
- BS/BA + 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
- Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards
- Ability to effectively negotiate and build collaboration amongst individuals
- Strong teamwork and collaborative skills
- Experience with manufacturing investigations, deviations, and CAPA
- General knowledge of aseptic manufacturing processes
- Proficient in MS Word, Excel, Power Point and other applications
- Strong interpersonal, verbal and written communication skills
- Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
- Willingness to think outside of the box and adapt best practices to a small, but growing environment
- Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
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