Overview
Incoming Quality Control Manager Jobs in Indianapolis, IN at Harba Solutions Inc.
Title: Incoming Quality Control Manager
Company: Harba Solutions Inc.
Location: Indianapolis, IN
Job Responsibilities:
- Hire, train, and coach a team of QC individual contributors; run performance reviews and set goals tied to department metrics.
- Build a team culture centered on rigor, ownership, and continuous improvement.
- Translate technical quality issues into plain language for site leadership, clients, and inspectors.
- Maintain the material specification and sampling-plan program for raw materials, components, and container closure systems.
- Coordinate physical sampling, in-house and outsourced analytical testing, and the associated inventory transactions.
- Author and issue inspection records; represent the group in material-readiness and production-planning meetings.
- Drive disposition of nonconforming or held incoming materials and lead the resulting investigations.
- Manage the full physical testing program for pre-filled syringes and autoinjectors, including: Container closure integrity testing (CCIT) via high voltage leak detection (HVLD)
- Glide force, break-loose force, and extrusion force testing on a Zwick universal testing machine
- Needle cap/shield removal force and cap removal force testing
- Activation, trigger, and injection force testing for autoinjector devices
- Keep all test instrumentation (Zwick, HVLD, force gauges) current on calibration and equipment qualification.
- Review test data for trends and anomalies, escalating issues promptly.
- Lead or oversee OOS/OOT and nonconformance investigations using structured root-cause tools (5-Why, fishbone).
- Ensure investigations close on time with defensible root causes and effective CAPAs.
- Own QC documentation; sampling plans, test methods, specs, and investigation reports within the QMS/LIMS.
- Help prepare for and host regulatory and client audits touching incoming quality or physical testing.
- Align testing requirements with Quality Assurance, Manufacturing, technical/process teams, Supply Chain, and Engineering across development, tech transfer, and commercial production.
- Act as the physical-testing subject matter expert in client and regulatory conversations.
Requirements:
- Bachelor’s degree in a life science or engineering discipline
- 7+ years in biopharma/pharma, including 3+ years managing people in a GMP environment
- 3+ years of hands-on QC physical testing experience with sterile injectables – pre-filled syringes and/or autoinjectors specifically
- Direct experience operating or managing Zwick testing equipment, HVLD instruments, and force gauges in GMP conditions
- Working knowledge of CCIT methodology, including HVLD
- Familiarity with relevant ISO standards for injection devices and quality systems (ISO 11608 series, ISO 23908, ISO 13485)
- Strong LIMS/JMP/Minitab or similar data-systems skills
- Experience participating in or hosting regulatory or client audits
- Able to pass annual vision screening, including color-blindness testing
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