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Actalent · 6 days ago
Principal QA Engineer
Maryland Heights, MO
Full-time
Onsite
Senior Level
8+ years exp
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Business DevelopmentBusiness Information Systems
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Responsibilities
Serve as the SME and Quality approver for GxP documentation for new products/projects.
Develop quality and validation project timelines and manage a sub team of 2 Quality Engineers.
Maintain operational compliance with US and international regulatory agencies and guidelines.
Review and approve Change Control/Management Documents involving product or process changes.
Act as a key personnel for FDA or other regulatory agencies for on-site audits.
Drive resolution of product complaints, exceptions, corrective actions, OOS’s, and safety issues.
Assemble, analyze, and report QA data to ensure regulatory compliance and identify areas of improvement.
Conduct quality audits, develop corrective action recommendations, and develop procedures/statistical evaluations.
Develop sampling plans, standard operating procedures, provide quality training, participate in Material Review Board meetings, and assist in preparation of regulatory submissions.
Qualification
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Required
Bachelor of Science in Biology, Chemistry, Life Sciences or related field required.
8 Or More Years Of Relevant Experience Required.
3 or years of experience in supporting on-site inspections for regulatory agencies.
2 years of demonstrated leadership experience on a project or in a position with direct reports
Significant Experience Investigating Exceptions And Other Variances.
Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems.
Working knowledge of cGMP guidelines and their application in a controlled aseptic environment.
Benefits
Health Insurance
Company
Actalent
Actalent is an engineering and sciences service company.
5,001-10,000 employees
H1B Sponsorship
Actalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (31)
2022 (63)
2021 (20)
Funding
Current Stage
Late StageLeadership Team
Scott Anderson
Chief Financial Officer
Alison Deming Bucek, SPHR, SHRM-SCP
Human Resource Business Partner
Recent News
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