Teams at INCOG BioPharma Services

Supports biopharma site compliance with regulations, ISO standards, and SOPs. Leads moderate-complexity compliance projects, reviews quality documentation and change controls, performs risk assessments, drafts procedures, and manages quality agreements and customer complaints. Builds customer-centered relationships, identifies and closes operational and quality gaps, communicates complex issues, and manages multiple projects independently. The role requires at least two years of biopharma quality assurance experience and may support after-hours activities.

Supervise daily Quality Control Microbiology activities, testing, data review, assignments, and laboratory support. Lead and mentor microbiology analysts and reviewers, oversee investigations and CAPA implementation, improve laboratory processes, ensure cGMP and regulatory compliance, and maintain inspection readiness. Provide technical leadership, perform laboratory walkthroughs, and collaborate with cross-functional leaders to achieve quality and business objectives.

Create, maintain, and update GMP-compliant technical documentation supporting pharmaceutical technical transfer and manufacturing activities. Develop batch records, process flow diagrams, FMEAs, reports, specifications, forms, manuals, and training materials. Collaborate with engineers and cross-functional teams to gather technical information, translate process data into clear reports, maintain document standards, manage electronic records, and incorporate subject matter expert feedback while supporting regulatory requirements.