Quality Assurance Specialist at US Tech Solutions

*Job Title: Quality Assurance Specialist (GMP/Pharma)

*Location: Frederick, MD

*Duration: 12 months contract, Full-Time

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).

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com