Lead Inspector, Parenteral QA & Team Coach

INCOG BioPharma Services; Fishers (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

INCOG BioPharma Services is seeking an Inspection Team Lead to monitor the inspection process and review batch records daily. You will mentor a team of 6–10 associates and ensure products meet quality standards in a cGMP environment at our Fishers, IN facility.

The role requires GMP experience, attention to detail, and the ability to work with cross-functional teams. Health and visual acuity checks are required annually, with emphasis on reliability, accuracy, and documentation discipline.

Qualifications

• 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.

Responsibilities

• 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 areas 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.

Skills

Math

Documentation

Education

High School diploma

Tools

ERP system

Job description

INCOG BioPharma Services is seeking an Inspection Team Lead to monitor the inspection process and review batch records daily. You will mentor a team of 6–10 associates and ensure products meet quality standards in a cGMP environment at our Fishers, IN facility.

The role requires GMP experience, attention to detail, and the ability to work with cross-functional teams. Health and visual acuity checks are required annually, with emphasis on reliability, accuracy, and documentation discipline.