Quality Coordinator, Qa Specialist - 2Nd Shift

Job Purpose Statement

The QA Specialist is responsible for performing Quality compliance activities on the production floor and ensuring that all activities are in compliance with company and regulatory guidelines and procedures. In addition, the QA Specialist is also responsible for assisting in activities directly related to batch release, and batch record and procedure review, revision and approval.

Main Accountabilities

Perform audits/checks of manufacturing, filling and packaging processes to include QA weight checks, line clearance activities, record review and signoff, cleaning verification label verification and reconciliation verification.

• Approve minor deviations on the operation floor.
• Review and approve executed batch records for completeness and accuracy for batch release.
• Verify and ensure compliance with regulatory and company procedures and guidelines.
• Perform investigations as required.
• Assist in other quality related functions as requested
• Additional tasks as assigned by Quality Management.

Job Related Qualification/Skills

• Bachelor’s degree in a scientific or related discipline from an accredited college or university OR
• Minimum of 3-7 years’ experience in the Pharmaceutical or regulated industry with prior experience in plant quality assurance.
• Demonstrated knowledge of cGMPs, other regulatory requirements for the manufacture, testing and release of pharmaceutical products.
• Strong proficiency in Microsoft Office suite of products, (Word, Excel, PowerPoint)
• Excellent verbal and written communication skills.

Excellent interpersonal, communications and organizational skills as well as the ability to work independently