Temp QA Compliance Associate I — 1st Shift (Mon-Fri)

Tolmar Inc.; Fort Collins (CO); On-site; USD 55,000 - 70,000; Full time

Job summary

Tolmar Inc. is seeking a Temporary Compliance Associate I for 1st shift (Mon-Fri 6:00am-2:30pm) at our Fort Collins site.

The role focuses on QA review of manufacturing batch records to ensure compliance with cGMPs, SOPs, and regulatory requirements, supporting product release. You will compile and review batch records, enter data into databases, investigate deviations, and coordinate with multiple departments to ensure timely release and accurate documentation.

Qualifications

• High School diploma or equivalent required.
• Associates degree in technical subject preferred.
• Three or more years of experience in the pharmaceutical or medical device industry in a Quality Assurance role.

Responsibilities

• Perform batch record compilation, review and maintenance.
• Perform detailed quality assurance review on executed batch records for commercial and development products.
• Make entries into databases and spreadsheets that support the production schedule and quality indicators.
• Perform investigation searches on executed batch records to ensure that deviations that apply to the batch record are known and can be assessed for closure by QA Management.
• Work with various departments to request needed records and correct batch record errors.
• Compile reviewed batch records into final complete executed batch record to make ready for final QA review for release of the product.
• Manage released batch records and forward for document scanning.
• Prioritize workload and coordinate activities to meet and support timely product release and ship schedules.
• Perform other duties as assigned.

Job description

Tolmar Inc. is seeking a Temporary Compliance Associate I for 1st shift (Mon-Fri 6:00am-2:30pm) at our Fort Collins site.

The role focuses on QA review of manufacturing batch records to ensure compliance with cGMPs, SOPs, and regulatory requirements, supporting product release. You will compile and review batch records, enter data into databases, investigate deviations, and coordinate with multiple departments to ensure timely release and accurate documentation.