QA Specialist - Biologics

at  Morgan McKinley

This role encompasses various responsibilities including Incoming Material Release, Batch Release, Change Control, Event Management, Supplier Qualification, Annual Product Review, and Validation Compliance activities.

WHAT YOU WILL DO:

• Review batch records and release materials to ensure adherence to GMP requirements.
• Administer event management systems, including reviewing and approving Events, Deviations, and Customer Complaints.
• Manage batch record design and approval processes.
• Administer the SAP Quality Management Module.
• Oversee site change control systems.
• Compile Annual Product Reviews.
• Support validation activities outlined in the Site Validation Master Plan.
• Review and approve validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
• Support system qualification and process validation activities.
• Review and approve SOPs, work instructions, and forms from other departments on behalf of Quality Assurance.
• Coordinate and assist in the preparation for regulatory and customer GMP inspections.
• Participate in New Product Introduction Teams.
• Conduct on-site and vendor facility GMP audits as needed.
• Conduct regular on-the-floor walkdowns to ensure adherence to GMP standards.
• Administer the site supplier approval process.