Inspection & Packaging Team Lead, 3rd Shift

INCOG BioPharma; Fishers (IN); On-site; USD 60,000 - 75,000; Full time

Job summary

INCOG BioPharma is seeking an Inspection/Packaging Team Lead to oversee the inspection and packaging of sterile drug products. This role involves monitoring processes, ensuring compliance with quality standards, and collaborating with teams. Candidates should have GMP experience and strong attention to detail.

Qualifications

• At least 2 years of GMP pharmaceutical experience in drug product inspection and/or packaging.
• Must pass health and visual acuity checks annually.

Responsibilities

• Perform continuous monitoring of the inspection process.
• Inspect filled products for cosmetic, particle, and integrity defects.
• Train and mentor new inspectors and associates.

Skills

Attention to Detail

Collaboration

Organization

Education

GMP Pharmaceutical Experience

Job description

Individual with Subject Matter Expert (SME) Capabilities in Inspection and Packaging

The Inspection/Packaging Lead is a key role within INCOG BioPharma Operations. The ideal candidate must have experience in the inspection and packaging of sterile drug products.

Primary Responsibilities

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 batch records and form entries. They will also perform inspections to identify and remove defects from finished products according to standard procedures. Ensuring compliance with quality standards, maintaining product quality, and minimizing equipment downtime are essential. The candidate will collaborate with internal partners, clients, and vendors to meet and exceed production standards.

This is a 3rd Shift position, with hours from 11:00 PM to 7:30 AM.

Essential Job Functions

1. Assist Inspection Supervisor in supporting a team of 6-10 associates in inspecting and packaging syringes and vials.
2. Follow production and manufacturing procedures.
3. Inspect filled products for cosmetic, particle, and integrity defects.
4. Reconcile finished inspected/packaged products and defects.
5. Assist in writing and implementing process documents.
6. Operate equipment per SOPs.
7. Ensure compliance with cGMP requirements.
8. Complete and review production records, logbooks, and forms.
9. Assist with Knapp and probability of detection studies.
10. Train and mentor new inspectors and associates.
11. Train new employees on inventory transactions in the ERP system.
12. Support other manufacturing functions as needed.
13. Perform duties in Grade C, D, and controlled non-classified cleanrooms.
14. Perform cleaning and sanitization activities.
15. Collaborate with cross-functional teams.
16. Work flexible hours for facility coverage.

Minimum Education and Experience

• At least 2 years of GMP pharmaceutical experience in drug product inspection and/or packaging.
• Must pass health and visual acuity checks annually.
• Keen attention to detail and ability to focus for extended periods.

Additional Preferences

• Manufacturing leadership experience.
• Good math and documentation skills.
• Ability to learn and adapt quickly.
• Good observation skills.
• Initiative and collaboration skills.
• Effective organization and diligence.
• Ability to work independently.

About INCOG BioPharma Services

We are building a world-class CDMO for parenteral injectable drugs, emphasizing service, technical excellence, and collaboration. Our GMP facility is being built from the ground up, offering opportunities to create innovative systems and processes. Positions are based in Fishers, IN. INCOG BioPharma is an Equal Opportunity Employer committed to diversity and inclusion.