Inspection Associate, 1st Shift
About The Position
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.
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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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
101-250 employees
