Senior QA Associate — GMP Compliance & Investigations

Tolmar Inc.; Fort Collins (CO); On-site; USD 34,000 - 37,000; Full time

Job summary

Tolmar Inc. in Fort Collins, CO is seeking aQuality Assurance Associate to ensure all Tolmar products are manufactured in accordance with GMP and internal specs.

You will inspect materials, components, and finished product, document results, and support quality oversight across departments and facilities. The role requires at least four years in pharmaceutical/medical device QA, a high school diploma or GED, and the ability to train others.

Qualifications

• High school diploma or GED required.
• Experience in a high volume manufacturing environment preferred.
• Experience in a Quality Assurance capacity in the pharmaceutical or medical device industry preferred.
• Four or more years’ experience in the pharmaceutical or medical device industry in a Quality Assurance capacity.

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.
• 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.

Education

High school diploma or GED

Tools

LIMS

Job description

Tolmar Inc. in Fort Collins, CO is seeking aQuality Assurance Associate to ensure all Tolmar products are manufactured in accordance with GMP and internal specs.

You will inspect materials, components, and finished product, document results, and support quality oversight across departments and facilities. The role requires at least four years in pharmaceutical/medical device QA, a high school diploma or GED, and the ability to train others.