QA Specialist – I

Job Description

Job Summary:

• The Quality Assurance Specialist will ensure compliance with the quality system’s procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Client quality objectives.

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.
• 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.)
• 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.)
• 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.