Jobs 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.

Authors and maintains engineering GMP documentation, including SOPs, work instructions, validation protocols, specifications, and change controls. Manages document lifecycles in an electronic document management system, supports deviations, root cause analyses, CAPAs, and master batch records, and develops training materials. Conducts document gap assessments, supports audits and inspections, and maintains an organized documentation library. Requires collaboration with engineering, manufacturing, quality, and technical teams in a regulated pharmaceutical manufacturing environment.

Reviews parenteral manufacturing batch records for cGMP, regulatory, and SOP compliance. Identifies corrections and deviations, coaches operations personnel, supports investigations and CAPA implementation, and contributes to SOP and work-instruction development. Coordinates reviews within production timelines and uses computerized systems to verify data integrity. Partners with Operations, Quality Systems, and other technical teams to support timely batch release and continuous compliance improvement.

Supports aseptic pharmaceutical manufacturing through deviation investigations, CAPA implementation, SOP and work-instruction development, root cause analysis, process improvement, FMEA participation, batch-record review, and productivity studies. Serves as a subject matter expert for preparation, formulation, and filling processes while partnering with operations, quality, and cross-functional teams. Uses manufacturing systems and data-analysis tools to maintain data integrity, improve process capability, and ensure cGMP, safety, and regulatory compliance.

Serve as the primary off-shift HR partner for a GMP-regulated biopharma facility. Advise operations and quality leaders, manage employee relations investigations, leave administration, performance improvement plans, compliance audits, HR policies, benefits questions, payroll training, workforce analytics, and cross-shift handoffs. The role is on-site Tuesday through Saturday from 4:30 p.m. to 12:30 a.m.

Leads supplier qualification, approval, auditing, documentation, change notification review, complaint investigations, risk assessments, quality agreements, and supplier quality metrics in a pharmaceutical GMP environment. Partners with Purchasing, Quality Operations, suppliers, and external auditors to maintain compliance, manage supplier risks, support product introductions, and drive quality improvements.

Leads the strategy, governance, implementation, integration, validation, and lifecycle management of regulated enterprise systems, including ERP, MES, CMMS, and VMS platforms. Oversees cross-functional applications teams, vendors, system architecture, data integrity, compliance, business process ownership, change management, operational support, KPIs, and continuous improvement across manufacturing, quality, supply chain, engineering, finance, and warehouse functions.

Supervise Manufacturing Training Specialists and oversee GxP classroom, OJT, competency assessment, curriculum administration, and training records. Ensure Veeva Vault training data is accurate, compliant, and audit-ready under FDA and ICH requirements. Coach staff, manage schedules, analyze training metrics, support audits, CAPA, deviations, and continuous improvement, and collaborate with Quality, Manufacturing, and technical teams to address training needs.

Leads the reliability organization supporting sterile fill/finish, inspection, autoinjector assembly, labeling, and packaging operations. Owns preventive and predictive maintenance, equipment lifecycle planning, spare parts, reliability metrics, troubleshooting, root cause analysis, GMP compliance, qualification support, continuous improvement, vendor management, budgets, and capital planning. Manages two supervisors and technician teams while partnering with Operations, Engineering, Quality, Supply Chain, and Technical Services.

Performs technical review of analytical and microbiological QC data for finished products, materials, stability, and environmental samples under GMP. Leads investigations, deviations, change controls, CAPAs, method improvements, technical writing, data integrity activities, and stability program management. Supports OpenLab and laboratory systems, instrument troubleshooting and calibration, client activities, regulatory documentation, and analyst mentoring.