QA Associate I - Process

TolmarWindsor, CO
5d$20Onsite

About The Position

The Quality Assurance Associate I is responsible for the inspection, testing, record keeping and overall quality assurance support to manufacturing.

Requirements

  • Working knowledge in drug or device cGMP.
  • Knowledge of computer operations, including proficiency with MS Word, Excel and Access.
  • Ability to learn Tolmar’s electronic systems.
  • Skill in organization and attention to detail.
  • Skill in effective written and oral communication.
  • Work independently and properly prioritize tasks with limited supervision.
  • Ability to work well with employees at all levels and departments.
  • Ability to read, understand and follow procedures.
  • Demonstrate competency in technical writing.
  • Ability to use critical thinking to address potential areas of concern.
  • High school diploma, GED, or equivalent required.
  • Ability to bend, squat, and lift minimum of 30 pounds required.
  • Ability to pass physical and eye exam required. Ability see color.

Nice To Haves

  • Associate’s degree preferred.
  • Experience in a high volume manufacturing environment preferred.
  • Experience in a Quality Assurance capacity in the pharmaceutical or medical device industry preferred.

Responsibilities

  • Inspect material, components, and finished product against specified requirements.
  • Follow procedures to determine status or disposition, and properly document results on records and in lab notebooks.
  • Support manufacturing and QC unit with inspections and material sampling.
  • Complete training according to requirements and maintain training records in the electronic document system.
  • Perform finished product inspections in accordance with specification; ensuring proper sampling has taken place prior to final release.
  • Provide process oversight support to manufacturing.
  • Ensure proper status and storage of materials and product.
  • Complete review and release of materials as required.
  • Provide quality oversight throughout multiple departments and facilities.
  • Initiate deviations and complete immediate actions.
  • Participate in monthly quality and safety walkthroughs.
  • Perform various other duties as assigned.

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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

251-500 employees

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