Inspection Associate, 3rd Shift

INCOG BioPharma Services; Fishers (IN); On-site; USD 35,000 - 45,000; Full time

Job summary

INCOG BioPharma Services in Fishers, Indiana, is seeking an Inspection Associate to ensure compliance with quality standards and perform inspections of sterile drug products. The role requires a high school diploma and a minimum of 1 year of GMP pharmaceutical experience.

Responsibilities include inspecting filled product containers, maintaining production standards, and training new inspectors. This position necessitates attention to detail and effective collaboration with internal and external partners.

Qualifications

• Minimum 1 year of GMP pharmaceutical experience in drug product inspection and/or packaging.
• Must pass health and visual checks annually for visual acuity and color blindness.

Responsibilities

• Inspect filled product containers for defects.
• Follow production and manufacturing procedures.
• Train new inspectors in accordance with certification procedures.
• Collaborate with cross-functional teams.

Skills

Attention to detail

Good math skills

Documentation skills

Observation skills

Collaborative

Education

High School diploma

Job description

Inspection Associate Summary

INCOG BioPharma Services is seeking a subject matter expert (SME) with capabilities in the inspection of sterile drug products. The Inspection Associate is a key role within the organization and must have experience in the inspection and packaging of pharmaceutical drug products.

The primary responsibility of the Inspection 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 or 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

• 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.

Special Job 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.

Additional Preferences

• 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.

Equal Opportunity Employer

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.