Inspection Team Lead Summary
Individual with subject matter expert (SME) capabilities in the inspection and of sterile drug products. The Inspection 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 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.
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 area’s 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
Special Job Requirements:
Minimum Education and Experience:
High School diploma required, 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
Additional Preferences:
Previous manufacturing leadership experience
Good math and documentation skills
Ability to perform repetitive tasks
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 we’ve 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.
Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges. In addition, we will offer customized packaging services to include labeling, device assembly, final packaging and integrated storage solutions at various temperature conditions.
