Temporary Compliance Associate I - 1st shift (Monday - Friday: 6:00am-2:30pm)

Tolmar Careers•Fort Collins, CO

About The Position

The QA Compliance Associate I provides Quality Assurance review of manufacturing batch records to support product release and ensure compliance with company Standard Operating Procedures (SOPs), policies, current Good Manufacturing Practices (cGMPs), and applicable FDA and global laws and regulations. This is a temporary assignment ending in March 2027, with core hours Monday through Friday, 6:00 a.m. to 2:30 p.m. The role compiles, reviews, maintains, and finalizes executed batch records for commercial and development products. It also supports production scheduling and quality indicators through database and spreadsheet entries, coordinates with other departments to obtain records and correct errors, and prepares completed records for final QA review and product release. Released batch records are managed and forwarded for document scanning. The associate prioritizes work and coordinates activities to support timely product release and shipping schedules. The position operates within Tolmar’s Core Values: Center on People; Are Proactive & Agile; Act Ethically; Constantly Improve; and Are Accountable. Working conditions are normal for an office environment. Pay is $25.00 per hour. A benefits summary is available, but not all benefits may apply because of the temporary nature of the position.

Requirements

High school diploma or equivalent.
Three or more years of experience in the pharmaceutical or medical device industry in a Quality Assurance role.
Knowledge of cGMPs and other documentation and regulatory requirements.
Organizational skills and attention to detail.
Effective written and oral communication skills.
Excellent troubleshooting and problem-solving skills.
Knowledge of computer operations, including proficiency with MS Word, Excel, and Access.
Ability to work independently.
Ability to work well with employees at all levels and departments.

Nice To Haves

Associate degree in a technical subject preferred.
Some college work in technical subjects is helpful.

Responsibilities

Compile, review, and maintain batch records.
Perform detailed QA reviews of executed batch records for commercial and development products.
Enter information into databases and spreadsheets supporting the production schedule and quality indicators.
Search executed batch records for applicable deviations so they can be assessed for closure by QA Management.
Work with various departments to request needed records and correct batch record errors.
Compile reviewed records into complete executed batch records for final QA review and product release.
Manage released batch records and forward them for document scanning.
Prioritize workload and coordinate activities to support timely product release and shipping schedules.
Perform other duties as assigned.