Inspection Team Lead, 3rd shift

INCOG BioPharma Services•Fishers, IN

11d•Onsite

About The Position

INCOG BioPharma Services is seeking a subject matter expert (SME) with capabilities in the inspection and/or packaging of sterile drug products. The Inspection/Packaging Associate is a key role within the organization. The ideal candidate must have experience in the inspection and packaging of pharmaceutical drug products. The primary responsibility of the Inspection/Packaging Associate is to perform continuous 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. 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.

Requirements

High School diploma required, minimum 1 year 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. Failure in vision test or annual recertification could result in termination.

Nice To Haves

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.

Responsibilities

Follow production and manufacturing procedures.
Inspect filled product container for cosmetic, particle and integrity 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).
Perform label and packaging activities for finished product.
Complete and review associated production records.
Train new inspectors in accordance with inspector certification procedures.
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.