Overview
QA Associate II – Process; 3rd Shift Jobs in Fort Collins, USA at TOLMAR Inc.
Position: QA Associate II – Process (3rd Shift)
Sunday – Wednesday, 5:00 pm – 5:30 am, every other Wednesday off
Purpose and Scope
The Quality Assurance Associate II ensures that all product manufactured at Tolmar is manufactured in accordance with current Good Manufacturing Practices (GMP) and meet all internal specifications. They will also provide oversight and guidance to manufacturing personnel in the performance of their duties.
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 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 (i.e. Packaging Engineering).
- Participate in monthly quality and safety walkthroughs.
- Perform finished product inspections in accordance with specification; ensuring proper sampling has taken place prior to final release.
- Provide process oversight support to manufacturing.
- Understand and use the electronic document/documentation system in the performance of duties.
- Suggest improvements to streamline inspection and documentation processes and work with manufacturing department to assure success.
- Demonstrate high level of proficiency in department job functions.
- Reach sound, effective conclusions and make quality decisions with little or no supervision.
- Assist Quality Assurance management with investigations.
- 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.
- Perform various other duties as assigned.
Knowledge, Skills & Abilities
- 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.
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Title: QA Associate II – Process; 3rd Shift
Company: TOLMAR Inc.
Location: Fort Collins, USA
Category:
