Temporary Compliance Associate I - 2nd shift (Monday - Friday: 2:00 pm - 10:30 pm)

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.
• Investigate 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

• Center on People: Support the well-being of patients and treat employees and those served as valued partners.
• Proactive & Agile: Embody a culture of engagement and action, adapt to change, anticipate, respond swiftly and efficiently.
• Act Ethically: Conduct business ethically, compliantly, and socially aware, cultivate diversity, equity, inclusion & sustainability.
• Constantly Improve: Enhance products, systems, processes, and services, reduce waste, increase efficiency, improve quality, embrace calculated risk-taking.
• Accountable: Be honest, transparent, and clear in alignment with core values, take accountability & ownership of work, actions, successes, and setbacks.

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.

Core Hours

Monday - Friday: 2:00 to 10:30 pm

Position Duration

Approximately 6 months

Compensation And Benefits

Pay: $25.00 per hour
Shift differential: $1.50 per hour

Benefits summary

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.