Sr. Quality Assurance Specialist
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Accentuate Staffing is partnering with a pharmaceutical, CDMO who is hiring for a Senior level, Quality Assurance Specialist. This is a contract to hire opportunity, working onsite. The ideal candidate has a bachelors degree in a scientific discipline, quality assurance and compliance experience within a GMP-regulated pharmaceutical manufacturing environment.
Responsibilities:
- Ensures compliance with all associated regulations, policies and procedures in a GMP manufacturing facility.
- Perform, review and approves both CAPAs and Change Controls.
- Manage documentation such as, Equipment Qualificaitons and Validations, Methods and Protocols, SOPs, Specifications, Batch Records, OOS, CAPAs, Deviations and Change Controls.
- Perform internal, external and quality system audits.
Requirements:
- Bachelor’s degree in a scientific discipline.
- Four plus years of experience in Compliance or QA related role within a GMP regulated, pharmaceutical environment.
- Five or more years of experience working as an analytical chemist and/or manufacturing process technician.
- Demonstrated problem solving skills and good documentation practices.
