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

Tolmar Careers • Windsor, CO

1d • $25

About The Position

The QA Compliance Associate I is responsible for providing the Quality Assurance review of manufacturing batch records in support of product release to ensure compliance in accordance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Practices (cGMPs), FDA and global laws and regulations.

Requirements

• Knowledge of cGMPs and other documentation and regulatory requirements.
• Skill in organization and attention to detail.
• Skill in effective written and oral communication.
• 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.
• High School diploma or equivalent required.
• Three or more years of experience in the pharmaceutical or medical device industry in a Quality Assurance role.

Nice To Haves

• Associates degree in technical subject preferred.
• Some college work in technical subjects helpful.

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.

Benefits

• Benefits summary: https://www.tolmar.com/careers/employee-benefits
• Please note that due to the temporary nature of this position, not all benefits may apply.
• Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED