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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
true
MCS Quality Assurance Specialist
Posted: 02/12/2026
2026-02-12
2026-03-20
Employment Type:
Contract
Job Category: Quality
Job Number: 4893
Job Description
This position supports the Quality Assurance program under the ATO Plant Quality Assurance organization providing oversight of Commissioning, Qualification, and Validation (CQV) processes in Cell Banking, Drug Substance, Drug Product Filling, Drug Product Packaging/Labeling, General Utility, and Quality Control GMP areas.
Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of CQV related processes, procedures, and use of quality systems.
Primarily responsible for ensuring adherence to equipment and computer validation standards and procedures.
Responsibilities:
Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of CQV related processes, procedures, and use of quality systems.
Primarily responsible for ensuring adherence to equipment and computer validation standards and procedures.
Responsibilities:
- Participation in CQV design, review of test protocols, analysis of CQV results, and oversight of summary reports.
- Provides guidance and sets standards in producing quality documentation and serves as an advisor to Engineering, IS and Manufacturing functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT compliance issues.
- Executes quality oversight directly in the client Quality systems.
- Bachelor’s degree in engineering, Biochemistry, Biology, Chemistry, or related science field.
- Demonstrated ability to perform or provide oversight of GMP operations including following detailed SOPS, maintaining training, maintaining data integrity principles, and good documentation practices.
- Experience managing projects through completion while meeting timelines.
- Evaluating documentation and operations according to company procedures and related regulations.
- Experience working with Quality Systems.
- Strong organizational skills and ability to manage multiple tasks at one time.
- Effective communication skills (both written and verbal).
- Demonstrated ability to work as both a team player and independently.
- Solid understanding and application of aseptic behaviors and principles
- Commissioning, Qualification, and Validation experience
- Experience with direct use of GMP quality systems (i.e. Deviation and Change Management, Equipment Maintenance and Lifecycle Management, Controlled Document Management systems)
- Direct experience working or supporting GMP manufacturing, Facility and Engineering, or Quality Assurance teams within the biotech industry
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