Senior Quality Assurance Specialist

Senior Quality Assurance Specialist needed to assist the Quality Assurance Manager in ensuring compliance with Quality Management Systems and Regulatory Agency requirements for the Rensselaer site. Responsibilities include conducting investigations of OOS, deviations, Change Control management, and CAPAs; cross-functional collaboration on Analytical Quality Assurance activities involving review of documents, qualifications, and reports related to QMS; developing, reviewing, and approving quality standards, policies, and procedures for cgmp functions; supporting regulatory inspections and preparation of CAPAs; leading GMP activities with manufacturing managers to complete deviation investigations on time; driving established quality metrics; reviewing/approving master batch records; managing customer audits and reporting updates to customers and management; reporting serious observations or compliance gaps to quality management; managing the Internal Audit program and coordinating auditors; interacting with the Curia Quality network to harmonize quality systems. Qualifications include a BS in Chemistry or related field, 8+ years in QA/RA/Compliance in pharma, strong knowledge of cGMP and regulatory guidelines (FDA, ICH, EU GMP), familiarity with APIs, and FDA inspection experience. Pay range listed is $103,000 - $129,300. Location is Rensselaer, NY, USA; role is on-site. Curia is an Equal Opportunity Employer and emphasizes compliance with safety and anti-discrimination policies.