Jonea Patterson

Inspection and Packaging Associate Summary

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

The primary responsibility of the Inspection/Packaging 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/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.

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