Incoming Inspector I (1st Shift)

Sharp ServicesAllentown, PA
Onsite

About The Position

Responsibilities include both visual and physical inspection of packaging, components and bulk product related to contract packaging. Additionally, participation in internal, external or regulatory audits will be required at the discretion of senior management. The impact of the quality inspection process directly impacts company compliance to regulatory requirements and customer satisfaction.

Requirements

  • Must pass a colorblindness test to assure they can detect if a color is out of specification.
  • Ability to apply moderately complex mathematical operations to assigned tasks. This includes an understanding of statistical sampling plans.
  • Ability to effectively communicate (either written or verbally) with internal departments (Quality, Warehouse, Materials Management and Account Management) and external groups (customer representatives and/or material suppliers).
  • A thorough understanding of each aspect of the job is required.
  • Ability to make rational decisions pertaining to quality compliance.
  • Ability to resolve problems effectively and efficiently.
  • Basic Windows applications including Microsoft Office Suite.
  • The employee frequently will sit to complete paperwork.
  • The employee is occasionally required to stand, walk, and reach with hands and arms.
  • The employee must occasionally lift and/or move up to 25 pounds.
  • Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

Nice To Haves

  • Experience in inspection of pharmaceutical or related industry is desired.
  • Outside certification of basic quality skills and practices (i.e. ASQ CQT, CQIA, CQI, etc.) is desired.
  • General knowledge of FDA regulations related to cGMPs is desired.
  • General knowledge of quality control/assurance is desired.
  • Experience with Lotus Notes and QAD desired.

Responsibilities

  • Responsible for execution, documentation and release of the evaluation of incoming components related to the packaging processes. This includes customer supplied, purchased and internally produced components.
  • Responsible for sampling components and bulk products using the guidelines established in the standard operating procedures or item specifications.
  • Responsible for the execution and documentation of required IR and Global Vision testing.
  • Responsible for reviewing work of peers and releasing components at the discretion of QA management.
  • Responsible for participating in internal, customer, and regulatory audits at the discretion of senior management.
  • Responsible for training of designated peers at management request.
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