QA Specialist
On-siteManatí, Manatí, Puerto Rico
Job Summary
Oversee QA compliance for pharmaceutical manufacturing clients by ensuring adherence to FDA, EMA, ICH, and global cGMP regulations. Review and approve quality documents including deviations, CAPAs, change controls, investigations, and validation deliverables across aseptic, sterile, and biologics production activities. Support internal and external audits, supplier reviews, and regulatory inspections while partnering with manufacturing, engineering, and regulatory teams to drive quality initiatives. Provide governance throughout the engineering project lifecycle, assessing batch documentation and quality events to maintain product standards. Requires 5+ years of QA experience in regulated environments and must be authorized to work in the U.S.
Required Qualifications
- Bachelor's degree in Life Sciences, Engineering, Chemistry, Biochemistry, Microbiology, or related field
- 5+ years of direct Quality Assurance experience within regulated pharmaceutical manufacturing environments
- Proven experience within aseptic manufacturing
- Extensive knowledge of FDA, EMA, ICH, and global GMP regulations
- Experience managing and supporting deviations, CAPAs, change controls, investigations, and quality risk management activities
- Strong understanding of Quality Control operations and laboratory compliance requirements
- Experience overseeing commissioning, qualification, validation, and engineering lifecycle activities
- Proven ability to work effectively across multiple functional areas and external manufacturing partners
- Strong verbal and written communication skills
- Must be authorized to work in the U.S.
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