Quality Assurance Specialist
Commissioning Partners LLC.
We are seeking a Quality Assurance Specialist to support GMP compliance, quality systems, manufacturing operations, and validation activities. Key Responsibilities: Review and approve GMP documentation, SOPs, protocols, reports, and batch records. Lead/support deviations, investigations, CAPA, change controls, and root cause analysis. Review and approve validation and qualification documentation. Support audits, inspections, risk assessments, and GMP compliance activities. Ensure compliance with FDA, cGMP, data integrity, and company quality requirements. Partner with Manufacturing, QC, Engineering, Validation, and Regulatory teams to resolve quality issues. Required Qualifications: Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field. 4+ years of pharmaceutical/biotech GMP experience. Strong knowledge of QA systems, deviations, CAPA, change control, validation, and regulatory compliance. #J-18808-Ljbffr
Vacancy posted 1 day ago
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