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Quality Assurance Inspector

Quality Assurance Inspector

 

 

 

This position assures that all products released for distribution comply with applicable specifications, all materials in warehouse are appropriately identified as to status and stored appropriately, only released materials are used in production, all materials are appropriately sampled and tested and meet specifications prior to their use in production, and the control and reconciliation of all pre-printed components are performed in a timely and accurate manner.

EDUCATION & EXPERIENCE

  • High School Diploma or equivalent (GED)
  • Bachelor’s Degree in Biology, Chemistry or related field of study preferred
  • Experience in pharmaceutical QA
  • Experience in pharmaceutical FDA compliance

TECHNICAL SKILLS

  • Good knowledge of SOPs
  • Complete understanding of Batch Records and Master Record File
  • Good communication skills
  • Good computer skills
  • Ability to make decisions consistent with SOPs
  • Ability to work independently
  • Good math skills

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to sit; climb or balance, stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. The employee must meet visual acuity requirements including color, depth perception, and field of vision.

POSITION RESPONSIBILITIES

  • Assure compliance with applicable SOPs.
  • Assure compliance of manufacturing with Batch Record Instructions and requirements.
  • Receive and sample raw materials and components for appropriate testing.
  • Appropriate quarantine and release of finished product for shipping.
  • Assure articles in the facility, be it raw materials, components, packaging, labels, finished product, reject materials, rework material, etc., are appropriately labeled and store in accordance with SOPs.
  • Inspect production line for cleanliness.
  • Appropriate sampling, storage, and status labeling of pallets of incoming materials until tested for compliance with specification and released for use.
  • Appropriate sampling, storage, of finished product until tested and released for production.
  • Review of batch records to assure only released ingredients, components, and labeling are used in production.
  • Physically assure all materials are stored where required and appropriately labeled as to status.
  • Assist Quality Management in product investigations where deviations have occurred in manufacturing, or complaints or product failure has occurred.
  • Oversee production units in proper adherence to company SOPs in the manufacture of product.
  • Maintain label inventory, issue labels to production, return labels to inventory and facilitate reconciliation of label inventory.
  • Maintaining, controlling, and verifying the reconciliation of all pre-printed components.
  • Participate in any investigations pertaining to issues regarding the reconciliation of pre-printed components.
  • Assure all bags are properly sealed/sewn and that pallets are appropriately stickered as to pallet status.
  • Immediately communicate any deviations to Production Supervisor and Quality Management.
  • Report production employees not complying with company SOPs in the execution of their responsibilities.
  • Inspect production lines including checking for PPE, labels, codes, weights, and compliance with specifications.

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