QA Specialist I

Role: Quality Assurance Specialist ensuring documentation and data integrity for raw materials, finished products, and stability activities within cGMP-regulated pharmaceutical manufacturing. Responsibilities: review notebooks, data sheets, reports, and batch records for compliance; support stability, validation, and annual reporting; perform product disposition, packaging audits, sample inspections, and monitor GMP areas for adherence. Qualifications: Bachelor's degree with 2+ years in QA/QC; strong understanding of laboratory testing (HPLC), data review, and cGMP standards; proficient in computer skills; experience in regulated environments; problem-solving, organizational, and communication skills. HighValue: pharmaceutical manufacturing, cGMP compliance, batch record review, stability, and validation support. WorkSetup: on-site with occasional travel; salary range $54,000-$78,000, with benefits.