Assistant Inspector Jobs in Indianapolis, IN (NOW HIRING)

Individual with subject matter expert (SME) capabilities in the inspection 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 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 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:

Aware of industry guidances and requirements applicable to visual inspection, including USP <790> and <1790> and FDA Draft Guidance: Inspection of Injectable Products for Visible Particulates (2021).

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.