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

Tolmar Inc.; Fort Collins (CO); Sur place; USD 55 000 - 70 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Description du poste

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

Job Category: Quality Assurance

Requisition Number: TEMPO005980

• Full-Time
• On-site

Description

Core Hours: Monday - Friday: 6:00am-2:30pm

This temporary assignment will end in March of 2027.

Purpose and Scope

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.

• 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.

Knowledge, Skills & Abilities

• 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.

Core Values

The QA Compliance Associate I is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the well-being of our patients and treat our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprise-wide mindset that lifts the whole organization.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity,inclusion& sustainability in our workplace.
• Constantly Improve: We are committed to a proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk-taking that drives better ways of working.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

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

Working Conditions

• Conditions are normal for an office environment.
• 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. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.