QA Associate III - Process (3rd Shift)

Tolmar•Fort Collins, CO

13d•$25 - $27•Hybrid

About The Position

The Quality Assurance Associate ensures that all product manufactured at Tolmar is manufactured in accordance with current Good Manufacturing Practices (GMP) and meets all internal specifications. They also continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements and efficiency.

Requirements

Working knowledge in drug or device cGMP.
Knowledge of computer operations, including proficiency with MS Word, Excel and Access.
Ability to learn Tolmar electronic systems.
Strong organizational skills and attention to detail.
Strong 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 non-conformances and potential areas of concern.
High school diploma or GED required.
Four or more years’ experience in the pharmaceutical or medical device industry in a Quality Assurance capacity.
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 materials, components, and finished product against specified requirements.
Follow procedures to determine status or disposition, and properly document results on records and in lab notebooks.
Perform inspection of retained drug product for Annual Product Reviews.
Support manufacturing and QC unit with inspections and material sampling.
Training of associates on various job functions.
Complete training according to requirements and maintain training records in the electronic document system.
Ensure proper status and storage of materials and product.
Provide materials to outside departments as requested.
Update, review and approve SOPs and work instructions using the electronic document management system.
Complete review and release of materials as required.
Provide quality oversight throughout multiple departments and facilities.
Initiate deviations, complete immediate actions and request assessments for non-conformances from appropriate groups.
Perform finished product inspections in accordance with specification; ensuring proper sampling has taken place prior to final release.
Understand and use the electronic document/documentation system in the performance of duties.
Provide process oversight support to manufacturing.
Suggest improvements to streamline inspection and documentation processes and work with manufacturing department to assure success.
Participate in monthly quality and safety walkthroughs.
Demonstrate high level of proficiency in department job functions.
Review temperature data loggers.
Act as a lead on investigations involving QA manufacturing support processes.
Complete corrective and preventative actions as determined through investigations.
Contribute to Competency Based Training (CBT) as a subject matter expert, acting in a Developer, Trainer or Assessor capacity.
Complete review and release of materials including generation of COA through LIMS.
Reach sound, effective conclusions and make quality decisions with little or no supervision.
Prioritize daily group tasks.
Create and maintain staffing schedule to ensure proper coverage at each facility.
Perform various other duties as assigned.