Specialist/Senior Specialist GMP QA - CMC Operations

Are you passionate about GMP quality assurance and CMC Operations? Join our client and help ensure top-tier standards every day. Proclinical is seeking a Specialist/Senior Specialist in Quality Assurance to support GMP manufacturing activities. In this role, you will provide expertise and guidance on GMP compliance, ensuring adherence to regulatory standards. This position involves oversight of batch records, deviation reviews, and other quality assurance processes. You will work collaboratively with cross-functional teams and contribute to maintaining high-quality standards in manufacturing operations.

Responsibilities

Develop and implement quality oversight strategies for contract manufacturing organizations (CMOs); Support regulatory inspections and internal audits; Review Master Production Batch Records, Executed Batch Records, analytical results, and supporting data packages; Complete batch record review checklists as applicable; Review and approve analytical methods, product specifications, method validation protocols, and reports; Oversee stability protocols, data tables, and stability reports; Manage and review deviations, out-of-specification (OOS) and out-of-trend (OOT) investigations; Oversee corrective action/preventive action (CAPA) activities and change control processes; Review and approve process validation protocols and reports; Investigate and manage product complaints and assist with recall or stock recovery investigations; Conduct QA GMP vendor audits and prepare audit reports; Stay updated on FDA, EU, and ICH regulations and advise on their impact on GMP activities; Collaborate with cross-functional project teams to ensure compliance and quality standards; Travel up to 25%, including international travel, as required

Requirements

Bachelor's degree in a scientific or related discipline; Experience in the biotech or pharmaceutical industry with a focus on Quality Assurance; Familiarity with EU, FDA, and ICH regulations and guidance documents; Strong organizational, prioritization, and time management skills; Proficient in computer applications and productivity software; Excellent oral and written communication skills; Ability to work effectively in cross-functional teams; Self-motivated with a strong focus on quality and attention to detail; Travel up to 25%, including international travel, as required

Nice to have

Advanced degrees; ASQ certification