Inspection Associate, 2nd Shift

INCOG BioPharma ServicesFishers, IN
4dOnsite

About The Position

INCOG BioPharma Services is seeking a subject matter expert (SME) with capabilities in the inspection 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.

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.

Nice To Haves

  • 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.

Responsibilities

  • 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.
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