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Fishers, Indiana, United States • On-site
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Oversee the full lifecycle review and disposition of parenteral manufacturing batch records while managing real-time floor review processes. Lead QA surveillance programs and participate in operational investigations to determine root causes and implement mitigations for deviating events.
Requires a Bachelor's degree in a related science and at least 5 years of experience with aseptic processing in cleanroom or isolator environments. Candidates must have 3 years of experience in batch record disposition and Quality Management Systems including Deviation/CAPA and Change Control.
Working closely with the QA Manager, the QA Batch Supervisor will be instrumental in supporting major QA programs. They will also be key in championing and developing the organization’s Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. The QA Batch Release Supervisor will at all times provide support with identifying and closing Operational and Quality gaps.
The Quality Assurance Batch Supervisor will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and external partners and clients. The QA Batch Supervisor will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Batch Supervisor will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Batch Supervisor will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.
· 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 escalate 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.
· 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.).
· 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.
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
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.
Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
By submitting your resume and details, you are declaring that the information is correct and accurate.
A CDMO with an unparalleled customer-centric approach.
Our services support injectable drug products, including technical transfer, analytical method development and validation, process scale up, and formulation & filling of vials, syringes and cartridges. In addition, we offer customized packaging services to include labeling, device assembly, auto injector assembly, cartoning, final packaging and integrated storage solutions at various temperature conditions.
Offices: Fishers , Indiana, US
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