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

Tolmar • Fort Collins, CO

7d

About The Position

The QA Compliance Associate I provides Quality Assurance review of manufacturing batch records in support of product release. The role ensures 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 scheduled to end in March 2027, with core hours Monday through Friday, 6:00 a.m. to 2:30 p.m. Work is performed under normal office-environment conditions.

The role reviews and maintains records for commercial and development products, supports production scheduling and quality indicators, coordinates with other departments to resolve record issues, and prepares completed records for final QA review and release. The position requires a high school diploma or equivalent and at least three years of pharmaceutical or medical device industry experience in a Quality Assurance role. An associate degree in a technical subject is preferred; some technical college coursework is helpful. Pay is $25.00 per hour. Tolmar notes that, because the position is temporary, not all benefits may apply; a benefits summary is provided at the linked careers page.

Requirements

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

Nice To Haves

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

Responsibilities

• Perform batch record compilation, review, and maintenance.
• Conduct detailed QA review 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.
• Coordinate with departments to request 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.

Benefits

• Benefits package; the employer notes that not all benefits may apply because the position is temporary. See the linked employee benefits summary for details.

What This Job Offers

• Career Level: Entry Level
• Education Level: High school or GED