QA Associate II - Process

Responsibilities

• Inspect materials, components, and finished products against specified requirements to ensure compliance with GMP.
• Provide quality oversight and guidance to manufacturing personnel during production processes.
• Perform inspections of retained drug products for Annual Product Reviews.
• Support manufacturing and QC units with material sampling and inspections.
• Initiate deviations, complete immediate actions, and request assessments for non-conformances.
• Update SOPs and work instructions using electronic document management systems.
• Complete review and release of materials as required.
• Assist Quality Assurance management with investigations and implement corrective/preventative actions.
• Participate in monthly quality and safety walkthroughs.

Requirements

• High school diploma or GED required.
• Working knowledge of drug or device cGMP.
• Proficiency in MS Word, Excel, and Access.
• Ability to lift a minimum of 30 pounds.
• Ability to pass a physical and eye exam, including the ability to see color.
• Ability to work 3rd shift (Sunday - Wednesday, 5:00 pm - 5:30 am).

Preferred Qualifications

• Associate’s degree.
• Two or more years of experience in a Quality Assurance capacity within the pharmaceutical or medical device industry.
• Experience working in a high-volume manufacturing environment.

Benefits

• Competitive hourly pay with a shift differential.
• Comprehensive benefits package.

About the Company

Tolmar is a pharmaceutical company dedicated to supporting the well-being of patients through ethical, compliant, and high-quality manufacturing processes. We foster a culture of continuous improvement, accountability, and proactive engagement.