Defect Kit Creation and Lifecycle Specialist

INCOG BioPharma Services • Fishers, IN

4d • Onsite

About The Position

INCOG Biopharma is seeking a detail oriented individual to support the creation, management, and maintenance of inspection defect kits. This role supports the Defect Kit Creation and Lifecycle Supervisor by executing day-to-day defect kit handling, inspection, documentation, and defect laboratory support activities in accordance with cGMP requirements and approved procedures.

The primary function of this role is to ensure defect kits and defect laboratory assets are maintained in a controlled, compliant, and inspection ready state. The Defect Kit Creation and Lifecycle Specialist performs routine inspections, preventative maintenance activities, inventory management, and documentation while supporting defect kit issuance and return processes.

Requirements

• Associates degree preferred; equivalent combination of education and hands-on GMP/visual inspection experience will be considered (2 years minimum).
• Familiarity with defect kits, defect classification, or inspection support activities.
• Ability to follow written procedures, complete controlled documentation, and maintain accurate records.
• Ability to obtain Uv Laser marker training.
• Passing of an eye exam required.
• Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals.

Nice To Haves

• Previous experience with CMMS.
• Experience supporting visual inspection programs or inspection training activities.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and process development.
• Familiarity with relevant quality and regulatory requirements and trends and cGMP's.
• Strong organizational skills with attention to detail and compliance.

Responsibilities

• Execute daily defect kit handling activities, including kit preparation, issuance, and storage.
• Maintain accurate defect kit inventory, including defect and good unit counts, location, and condition status.
• Perform routine preventive maintenance (PM) activities per approved procedures.
• Identify and report damaged, missing, or compromised defect kit units to management.
• Support defect creation, characterization, and defect sizing when trained and authorized.
• Support visual inspection training, qualification, and requalification activities by preparing and staging defect kits as needed.
• Comply with cGMP requirements, internal SOPs, and safety policies.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree