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

Description

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

This position's duration will be approximately 6 months.

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.

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.
• Perform other duties as assigned.

Knowledge, Skills & Abilities

Core Values

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

Education & Experience

Working Conditions

Compensation and Benefits

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.

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.