QA Specialist II

QA Specialist II Details:

• Contract position
• $38.00 to $45.00 /hour
• First Shift (Monday through Friday)

• The QA Specialist II performs the day-to-day activities of the Quality Assurance department to ensure drug substances manufactured comply with FDA and international regulatory requirements for research, pre-clinical, clinical, and commercial purposes.

• Review batch records in a timely manner and with high accuracy.

• Perform production room, dispensary and shipment clearance verifications

• Revise established standard operating procedures (SOPs) as well as other GMP documents (e.g. stability protocols, raw material specifications, EM trend reports) as assigned.

• Manage GMP documentation and their workflows as required by the department

• Coordinate, review and approve quality events • Provide support for regulatory, customer, and internal audits

• Drive continuous improvements and represents QA in process improvement project teams

• Implements and maintains Quality Management System.

• Scan, verify and archive GMP records (internal and external).

• Represent QA in project teams (e.g. – harmonization of systems/processes across other facilities, implementation of new systems/processes)