QA Associate I - Process (3rd Shift)

Tolmar•Fort Collins, CO

1d•Onsite

About The Position

The Quality Assurance Associate I is responsible for the inspection, testing, record keeping and overall quality assurance support to manufacturing. This role operates within the framework of Tolmar’s Core Values: Center on People, Are Proactive & Agile, Act Ethically, Constantly Improve, and Are Accountable.

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.