• 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.
• Perform other duties as assigned

Basic Qualifications:

• 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.