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Description
This is a unique opportunity to join INCOG BioPharma's Quality Assurance team in a highly visible role that directly supports the delivery of safe, effective parenteral drug products to patients worldwide. Reporting to the QA Director of Quality Systems, you will be part of a collaborative, fast-paced environment where your expertise in inspection, labeling, packaging, and serialization quality systems will shape the future of our CDMO operations. If you thrive in a culture of innovation and continuous improvement, this is the role for you.
The QA Senior Engineer of Inspection, Labeling, and Packaging is responsible for the oversight and continuous improvement of quality systems governing finished product inspection of aseptically filled vials, syringes, and cartridges, as well as labeling, packaging, and serialization operations. This role ensures that all associated quality systems are designed, implemented, and maintained in a state of regulatory compliance with FDA, EMA, and other applicable regulatory requirements. The QA Senior Engineer serves as a subject matter expert (SME) and key quality partner to Manufacturing, Technical Services, Engineering, and Supply Chain teams to drive operational excellence and inspection readiness across all inspection, labeling, and packaging activities.
Essential Job Functions:
• Provide quality oversight and SME support for finished product visual inspection operations, including manual, semi-automated, and automated inspection of filled vials, syringes, and cartridges
• Own and manage quality systems related to labeling, packaging, and serialization, ensuring compliance with FDA and EMA regulations; USP/ISO/ICH/PDA/ISPE and other non-governmental guidance documents. and applicable serialization regulations (e.g., DSCSA)
• Author, review, and approve SOPs, work instructions, batch record sections, and specifications related to inspection, labeling, packaging, and serialization processes
• Lead or support deviation investigations, root cause analyses, and CAPA activities related to inspection defects, labeling errors, packaging failures, and serialization events
• Collaborate with Manufacturing, Engineering, and Technical Services to develop and qualify inspection parameters, AQL criteria, and defect libraries for new and existing products
• Ensure inspection, labeling, and packaging quality systems maintain audit and inspection readiness for FDA, EMA, and client audits
• Oversee process validation activities for inspection equipment, labeling systems, packaging lines, and serialization/aggregation systems
• Review and approve change controls, risk assessments, and validation protocols/reports impacting inspection, labeling, and packaging operations
• Support QA floor oversight as an SME for escalations during inspection, labeling, and packaging operations.
• Stay current with evolving regulatory expectations and industry best practices for parenteral product inspection, labeling, packaging, and serialization
Special Job Requirements:
• Bachelor's degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, Engineering) required, or 10+ years experience in an Quality and/or Engineering role with similar responsibilities in lieu of a degree
• Minimum of 5 years of experience in pharmaceutical or biopharmaceutical Quality Assurance, with direct experience in developing and maintaining site or corporate level quality systems for finished product inspection, labeling, packaging, and serialization operations
• Minimum of 3 years of experience in a GMP-regulated parenteral/sterile injectable manufacturing environment
• Demonstrated knowledge of FDA regulations (21 CFR Parts 210, 211), EU GMP Annex 1, ICH guidelines, inspection guidances (USP <790> and <1790>, PDA TRs, and applicable serialization regulations (DSCSA, EU FMD)
• Experience with visual inspection methods (manual and automated), AQL sampling plans, and defect classification systems for injectable drug products
• Strong understanding of quality system elements including deviations, CAPAs, change controls, risk assessments, and document management within a QMS
• Experience supporting deviation investigations and CAPA lifecycle management, including root cause analysis, effectiveness checks, and timely closure in compliance with site quality system procedures
• Experience supporting client audits and regulatory inspections (e.g., FDA, EMA, or other health authority), including preparation of audit-ready documentation, back-room support, and response to observations
• Experience supporting regulatory inspections (FDA, EMA, or other health authority) and client audits
Additional Preferences:
• Experience in a CDMO or contract manufacturing environment, supporting multiple client programs simultaneously
• Familiarity with automated inspection technologies, high-speed labeling and packaging, and serialization/track-and-trace platforms
• Experience with process validation lifecycle approach, including Stage 1, 2, and 3 activities for inspection, labeling, and packaging equipment
• ASQ Certified Quality Engineer (CQE) or similar professional certification
Additional info about INCOG BioPharma Services:
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.
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