GMP QA Associate III – Quality Assurance Specialist

Tolmar-7; Fort Collins (CO); On-site; USD 22,042,000 - 37,195,000; Full time

Job summary

Tolmar is seeking a Quality Assurance Associate to ensure all products are manufactured according to current Good Manufacturing Practices (GMP) and internal specifications. You will monitor systems, inspect materials, document results, and support multiple departments across Tolmar facilities in Colorado.

Responsibilities include training, reviewing SOPs, initiating deviations, and generating COAs through LIMS, with a focus on timely inspections, accurate data, and continuous quality

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 and maintain training records in the electronic document system.
• 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; ensure proper sampling.
• 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.
• Contribute to 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.

Skills

MS Word

Excel

Access

Attention to detail

Written and oral communication

Independent work

Read and follow procedures

Education

High school diploma or GED

Tools

LIMS

EDMS

Job description

Tolmar is seeking a Quality Assurance Associate to ensure all products are manufactured according to current Good Manufacturing Practices (GMP) and internal specifications. You will monitor systems, inspect materials, document results, and support multiple departments across Tolmar facilities in Colorado.

Responsibilities include training, reviewing SOPs, initiating deviations, and generating COAs through LIMS, with a focus on timely inspections, accurate data, and continuous quality