Defect Kit Creation and Lifecycle Specialist
INCOG BioPharma Services, Fishers, Indiana, us, 46085
Description
Defect Kit Creation and Lifecycle Specialist Summary
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.
Essential Job Functions:
• 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.
Special Job 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.
Additional Preferences:
• 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.
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.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Defect Kit Creation and Lifecycle Specialist Summary
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.
Essential Job Functions:
• 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.
Special Job 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.
Additional Preferences:
• 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.
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.
By submitting your resume and details, you are declaring that the information is correct and accurate.