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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
true
Quality Assurance Specialist
Posted: 02/17/2026
2026-02-17
2026-03-20
Employment Type:
Contract
Job Category: Quality
Job Number: 4868
Job Description
The Quality Assurance Specialist will provide quality support and oversight of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. They will collaborate cross-functionally to ensure project timelines and milestones are met.
Primary Responsibilities:
Primary Responsibilities:
- Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance.
- Perform quality review of documents to support facility commissioning and qualification, according to project timelines.
- Commissioning / Qualification Protocols
- Performance Qualification Protocols (PQ)
- Review and Approval of protocol discrepancies
- Review of Final Reports and Summary Documents
- Provide quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required.
- Ensure that all activities & related documentation for facilities, equipment, materials, and processes comply with applicable regulations and company requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
- Ensure documents comply with company procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices (GDP).
- Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies.
- Participate in meetings related to document planning, execution, and issue resolution.
- Escalate any compliance concerns or critical gaps to QA management.
- In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
- Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
- Understanding of regulatory requirements, trends, and industry standards.
- Experience/knowledge in commissioning/qualification/validation, including computer-systems validation.
- Excellent written and verbal communication skills.
- Ability to work in a team matrix environment and build relationships with partners.
- Great attention to detail and high degree of accuracy in task execution and GMP documentation.
- Ability to complete tasks autonomously, providing updates to senior management, identifying potential issues, and following assignments through to completion.
- Proven capability and experience applying GMP requirements in an operational and Quality Control setting.
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