Inspection Team Lead, 3rd Shift

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.

The hours for the Inspection Team Lead, 3rd Shift are 10:00pm - 6:30am.

• Assist Inspection Supervisor, supporting a team of 6 to 10 associates daily, to inspect 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

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 and FDA Draft Guidance: Inspection of Injectable Products for Visible Particulates (2021).

• 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

• 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

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.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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.