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

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

Purpose and Scope

The QA Compliance Associate II 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. Provides guidance in Good Documentation Practices. Provides training to departmental associates.

Essential Duties & 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.
• Manage the inventory of department supplies and replenish when levels are low.
• Review downloaded data from temperature monitoring devices to support storage conditions of product.
• Perform batch record review on multiple product lines, including those that contain complex process activities.
• Act as backup to maintain spreadsheets used to track current issues and production planning updates.
• Train Compliance Associates as needed.
• 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 II 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. We are committed to treating 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.
• 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 collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• 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.
• Five 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.

Compensation and Benefits

• Pay: $30.00 per hour
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

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.