Commercial GMP Quality Assurance Specialist (Contract)

JOB DESCRIPTION: 

Sound understanding of GMP principles and their application to product quality and compliance, supporting commercial paper-based Executed Batch Record (EBR) and disposition of Drug Substance (DS)/ Active Pharmaceutical Ingredient (API), Spray Dried Dispersion (SDD), and/ or Drug Product (DP). The ideal candidate will have a strong background in EBR review, disposition, Contract Development, and Manufacturing Organization (CDMO) experience and a background in biopharmaceuticals. 

 
KEY RESPONSIBILITIES: 

Include the following but are not just limited to: 

• Supports and/ or leads product quality investigations (manufacturing process, analytical, and operations), ensuring they are adequate and cGMP compliant. 

• Supports and/ or leads product and process change controls as needed. 

• Identifies and recommends appropriate CAPA as needed for investigations and evaluates CAPA effectiveness check. 

• Performs GMP document review ranging anywhere from Executed to Master Batch Records (MBR/ EBR), archival and may support process validation-related activities and documentation. 

• Supports collaborative efforts for and with audit and inspection teams. 

• Tracks and trends metrics that are product or process related as directed by the management. 

• Ensures risks are identified, communicated and critical issues are escalated, followed up through until addressed, and proactively assists with risk mitigation plans. 

• Works independently and meets timelines, objectives, and deliverables in principle. 

Knowledge and Skills: 

• Able to support multiple projects/ cross-functional teams and members within stated objectives and timelines and collaborate effectively. 

• Effective communication skills with the ability to process, simplify, and communicate potentially complex information. 

• Ability to work independently even in challenging environments, think critically, support evaluation of product quality matters, and exercise sound judgment based on precedent, with rationale. 

• Sound understanding of cGMP manufacturing and testing principles, deviations, investigations, Root Cause Analysis (RCA), change controls, and CAPA in a pharmaceutical setting. 

• Ability to work on various document management quality systems. 

 
Education and Experience: 

• Associate/ Bachelor’s degree in a scientific field with 2-5 or more years of relevant work experience and/or the equivalent combination of education and experience. 

• Experience providing commercial quality support and cGMP oversight of manufacturing operations, with an exclusive focus on batch release 

• Experience with DS/API, SDD, and DP small molecule (oral solid dosage forms preferred) 

• Knowledge of cGMP requirements governing oral drug products manufacturing practices