QA Specialist - I - US Tech Solutions, Inc.
Maryland, MD 21704
About the Job
Job Description:
Responsibilities:
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.
- 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
- Experience with manufacturing investigations, deviations, and CAPA.
- Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards.
- 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).
Source : US Tech Solutions, Inc.