QA Specialist - I

Job Description: 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. • 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. • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues. Experience: • 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. • 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 Skills: • Experience with manufacturing investigations, deviations, and CAPA. • Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards. Education: • MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) • BA/BS 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) • Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 4+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) • High School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product