INCOG BioPharma Services
Inspection & Packaging Team Lead, 3rd Shift
INCOG BioPharma Services, Fishers, Indiana, us, 46085
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Inspection & Packaging Team Lead, 3rd Shift
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INCOG BioPharma Services 3 weeks ago Be among the first 25 applicants Join to apply for the
Inspection & Packaging Team Lead, 3rd Shift
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INCOG BioPharma Services Get AI-powered advice on this job and more exclusive features. Individual with subject matter expert (SME) capabilities in the inspection and/or packaging of sterile drug products. TheInspection/Packaging Lead is a key role within INCOG BioPharma Operations. The ideal candidate must have experience in the inspection and packaging of pharmaceutical drug products.
The primary responsibility of the Inspection/Packaging Team Lead is to perform continuous monitoring of the inspection process and provide in-process daily review of executed batch record and form entries. In addition, they will perform inspection to identify and remove critical, major, and minor defects from finished product according to standard procedures. They will be responsible for meeting/exceeding production standards, maintaining product quality, and minimizing/preventing equipment downtime. The ideal candidate will ensure compliance with quality systems, policies, procedures, and cGMP practices and collaborate effectively with internal partners, clients, and vendors.
This is a 3rd Shift position, with typical hours from 11:00PM-7:30AM.
Essential Job Functions:
Assist Inspection Supervisor, supporting a team of 6 to 10 associates daily, to inspect and package syringes and vials. Follow production and manufacturing procedures. Inspect filled product container for cosmetic, particle and integrity defects. Perform reconciliation of finished inspected/packaged product and defects. Assist in writing and implementing areas process documents. Operate equipment in compliance with SOPs. Assure compliance with cGMP requirements (current good manufacturing practices). Complete and review associated production records, logbooks and forms. Assist in performing and documenting Knapp and probability of detection studies. Train new inspectors in accordance with inspector certification procedures. Mentor new inspection / packaging associates. Train new employees to perform manufacturing inventory transactions in the ERP system. Assist other manufacturing functions (Formulation, Fill, Materials) as required. Perform duties gowned in Grade C, D, and controlled non-classified cleanrooms. Perform cleaning and sanitization activities as needed. Collaborate and communicate with cross functional teams. Work flexible hours to ensure production facility coverage.
Minimum Education and Experience:
Minimum 2 years of GMP pharmaceutical experience in drug product inspection and/or packaging Must pass health and visual check and eye inspections annually for visual acuity and color blindness Keen attention to detail and ability to focus for extended periods
Additional Preferences:
Previous manufacturing leadership experience Good math and documentation skills Ability to learn and adapt to innovative ideas Good observation skills Initiative-taking and Collaborative Effective organization skills and diligent Ability to work with minimal supervision
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we are building 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.
We are in the process of constructing the GMP facility and organization from the ground-up, which gives us the opportunity to leverage the knowledge weve gained over our careers to do it right in all respects. 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.
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.
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Inspection & Packaging Team Lead, 3rd Shift
role at
INCOG BioPharma Services 3 weeks ago Be among the first 25 applicants Join to apply for the
Inspection & Packaging Team Lead, 3rd Shift
role at
INCOG BioPharma Services Get AI-powered advice on this job and more exclusive features. Individual with subject matter expert (SME) capabilities in the inspection and/or packaging of sterile drug products. TheInspection/Packaging Lead is a key role within INCOG BioPharma Operations. The ideal candidate must have experience in the inspection and packaging of pharmaceutical drug products.
The primary responsibility of the Inspection/Packaging Team Lead is to perform continuous monitoring of the inspection process and provide in-process daily review of executed batch record and form entries. In addition, they will perform inspection to identify and remove critical, major, and minor defects from finished product according to standard procedures. They will be responsible for meeting/exceeding production standards, maintaining product quality, and minimizing/preventing equipment downtime. The ideal candidate will ensure compliance with quality systems, policies, procedures, and cGMP practices and collaborate effectively with internal partners, clients, and vendors.
This is a 3rd Shift position, with typical hours from 11:00PM-7:30AM.
Essential Job Functions:
Assist Inspection Supervisor, supporting a team of 6 to 10 associates daily, to inspect and package syringes and vials. Follow production and manufacturing procedures. Inspect filled product container for cosmetic, particle and integrity defects. Perform reconciliation of finished inspected/packaged product and defects. Assist in writing and implementing areas process documents. Operate equipment in compliance with SOPs. Assure compliance with cGMP requirements (current good manufacturing practices). Complete and review associated production records, logbooks and forms. Assist in performing and documenting Knapp and probability of detection studies. Train new inspectors in accordance with inspector certification procedures. Mentor new inspection / packaging associates. Train new employees to perform manufacturing inventory transactions in the ERP system. Assist other manufacturing functions (Formulation, Fill, Materials) as required. Perform duties gowned in Grade C, D, and controlled non-classified cleanrooms. Perform cleaning and sanitization activities as needed. Collaborate and communicate with cross functional teams. Work flexible hours to ensure production facility coverage.
Minimum Education and Experience:
Minimum 2 years of GMP pharmaceutical experience in drug product inspection and/or packaging Must pass health and visual check and eye inspections annually for visual acuity and color blindness Keen attention to detail and ability to focus for extended periods
Additional Preferences:
Previous manufacturing leadership experience Good math and documentation skills Ability to learn and adapt to innovative ideas Good observation skills Initiative-taking and Collaborative Effective organization skills and diligent Ability to work with minimal supervision
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we are building 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.
We are in the process of constructing the GMP facility and organization from the ground-up, which gives us the opportunity to leverage the knowledge weve gained over our careers to do it right in all respects. 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.
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.
Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Information Technology Industries
Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at INCOG BioPharma Services by 2x Get notified about new Packager jobs in
Fishers, IN . Inspection & Packaging Associate, 3rd Shift
Inspection & Packaging Training Specialist, 1st Shift
Corrugated Packaging and Display Project Team Lead 1071954
Inspection & Packaging Training Specialist, 3rd Shift
Indianapolis, IN $64,500.00-$167,200.00 3 weeks ago Corrugated Packaging and Display Project Team Lead
Indianapolis, IN $100,000.00-$120,000.00 1 week ago Fishers, IN $150,000.00-$160,000.00 5 days ago Sr. Principal Scientist - TS/MS Device & Packaging
Indianapolis, IN $114,000.00-$198,000.00 3 days ago Indianapolis, IN $63,000.00-$162,800.00 2 weeks ago Indianapolis, IN $64,500.00-$167,200.00 4 days ago Indianapolis, IN $63,000.00-$162,800.00 4 days ago Indianapolis, IN $20.51-$20.51 1 month ago Indiana, United States $40,000.00-$52,300.00 4 days ago Fishers, IN $55,000.00-$70,000.00 2 weeks ago Indianapolis, IN $18.00-$21.00 1 month ago Sr. Principal Scientist - TS/MS Device & Packaging
Indianapolis, IN $114,000.00-$198,000.00 3 weeks ago Engineer - Serialization Lead, Packaging and Automation
Indianapolis, IN $64,500.00-$167,200.00 1 week ago Delegate Experience Collegiate Assistant
Lead Secondary Packaging Development Engineer
Indianapolis, IN $64,500.00-$167,200.00 3 days ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr