Supervisor, QA Operations at ALK-Abello, Inc – Oklahoma City, Oklahoma

Area of Responsibilities

Quality Assurance Operations Supervisor responsibilities include ensuring training of direct reportees, metrics, review of investigations, change controls, CAPAs, batch records, validations. Ensure that all products manufactured conform to safety and quality standards. This ensures that shipped finished product fulfills all customer specifications and quality requirements. The Quality Assurance Operations Supervisor must strictly follow quality standards and meet daily, weekly or monthly goals.

• Oversee timely completion of APQRs
• Oversee record retention and coordinate with relevant departments to ensure organization of document control area
• Maintain Aseptic Process Simulation test kits
• Assist regulatory with DMF updates as necessary
• Oversee product retention sample area
• Maintain and report QA plant Metrics
• Update Quality Systems Informational Packet as necessary
• Ensure timely issuance and final release of batch records
• Oversee quality assurance responsibilities involving environmental monitoring
• Review and approve relevant documents
• Performing SAP functions as required
• Assist in product and mock recalls as necessary
• Author, review, and/or approve relevant deviations, change cases, quality acts, etc.
• Responsible for overseeing incoming material quarantine, release, and rejection
• Ensuring adequate and timely completion of direct reportee training
• Review, comment, and approve validation protocols, media fill reports, etc.
• Participate in health authority inspections, customer audits, and global quality audits
• Follow area SOPs and WINs
• Oversee annual site GMP training
• Document work according to established SOPs
• Participate and hold company meetings
• Maintain personal development of reportees within relevant areas
• Backup to QA Manager for relevant responsibilities
• Other duties may be assigned