Quality Assurance Manager

Title: QA Manager

Location: Albany, GA

Type: Onsite

Comp: Salary Benefits Bonus

Position Purpose:

The Quality Assurance Manager is responsible for managing site Change Control, Document Control, Quality Records, and Component Review processes. The role oversees quality system compliance, product disposition, production batch control, supplier qualification support, GMP documentation, complaint/site investigations, quality metrics, audits, and continuous improvement. The position also supports inventory, MRO/Storeroom, SAP/EAMS, and maintenance-related activities.

Duties and Responsibilities:

• Manage and administer the Change Control and Document Control systems.
• Approve Change Controls and maintain production material specifications.
• Support product disposition, batch release, complaint review, and supplier qualification.
• Coordinate Site Quality Review Team meetings, agendas, minutes, and quality reports.
• Monitor quality system performance, metrics, and audit readiness.
• Participate in internal/external audits and support CAPA activities.
• Prepare and implement SOPs and GMP documentation.
• Support continuous improvement initiatives, including Lean/Six Sigma.
• Manage at least one direct report.
• Manage inventory, cycle counts, MRO/Storeroom requisitions, critical spares, and MIN-MAX levels.
• Maintain parts and materials in SAP/EAMS/CMMS systems.
• Coordinate suppliers, service contractors, POs, deliveries, and supplier corrective actions.
• Support preventive/corrective maintenance parts kitting and maintenance planning.
• Conduct Storeroom and hazardous waste audits.
• Work with Maintenance, Engineering, Reliability, EHS, Procurement, and other cross-functional teams.
• Perform other duties as assigned by management.

Experience Requirements:

• Bachelor’s degree in Chemistry, Engineering, or related Science field.
• 3 years of Quality Assurance experience in a GMP-regulated pharmaceutical or medical device environment.
• Experience with Change Control and/or Raw Material Release required.
• Experience with TrackWise (QTS) or similar quality systems.
• Experience with Document Management Systems.
• Knowledge of 21 CFR Part 820 and ISO 13485 preferred.
• SAP experience preferred.
• Knowledge of Lean/Six Sigma highly desirable.
• ASQ auditing experience/certification highly desirable.
• Supervisory experience preferred.
• Strong communication, organizational, problem-solving, and customer service skills.
• Ability to manage multiple priorities and work effectively with cross-functional teams.
• Understanding of regulatory and production requirements in medical device manufacturing.