QA Batch Release Supervisor - IDAPINCOG BioPharma Services • Fishers, Indiana, United States
QA Batch Release Supervisor - IDAP
INCOG BioPharma Services
- Fishers, Indiana, United States
- Fishers, Indiana, United States
About
Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product. Manage and oversee the Batch Record “real‑time” floor review process. Provide Client access and support in the review and approval of Batch Records. Design and own an ongoing QA Surveillance program for the assurance of compliance standards in operations areas. Provide training to all QA Associates and Specialists on surveillance oversight and on‑the‑floor Batch Record review requirements. Participate in operations investigations for determining root cause and assessing mitigation for Major and Critical deviating events. Responsible for updating SOP’s & Work Instructions. Support Plant Automation alarm reviews. Advise and approve the builds of Batch Record BOMs and ECOs. Prioritize and coordinate their time in balancing production timelines with product quality assurances. Exercise rapid decision‑making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalating the issue to Manager for resolution. Provide support as needed in a cross‑functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. Utilize various paper and automated systems (eDMS, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. Ability to manage multiple projects in a fast‑paced environment. Special Job Requirements
Bachelor’s Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.). 5 years minimum experience working with aseptic processing in cleanroom and/or isolator environments required. 3 years minimum experience of oversight of aseptic manufacturing and all production stage batch record review and disposition required. 3 years experience as performer or reviewer in Quality Management Systems, DMS, Deviation/CAPA, and Change Control required. Extensive knowledge of regulations and quality processes involving product disposition. Excellent written and verbal communication skills. General computer skills evidenced by hands‑on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences
2 years’ experience with assessment and review of Quality Control testing, CoA, and results management preferred. 2 years’ experience as a team/people leader preferred. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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Languages
- English
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