Quality Control Operation Lab Manager
The QC Operation Lab Manager will lead and manage the GMP commissioning program of equipment and instruments. This role ensures the equipment and instruments within the QC are Qualified, Calibrated and Maintained according to the specified standards and procedures according to GMP compliance. This role will also support Computerized System Validation for QC and serve as administrator for user account maintenance.
Responsibilities
• Leading the GMP commissioning and qualification process (IQOQPQ, data integrity and audit trails, tagging) by drafting and approving protocols/reports, coordinating cross functional activities (including vendors and contractors).
• Managing the lab’s Calibration and Preventive Maintenance program by working with outside contractors.
• Providing guidance and direction to contractors to ensure compliance to procedures.
• Coordinating with equipment vendors when significant repairs are needed.
• Creating and maintaining the company’s Calibration and PM program.
• Ensuring that policies, directives, and regulatory authority guidance (GMPs) are followed.
• Initiating equipment/instrument related complex deviations, CAPAs etc. and leading efforts to close out these events.
• Drafting complex SOPs, complex OIs and Best Practices and making sure they are aligned with base SOPs.
• Leading cross-functional activities (QA, technical operations) to develop Quality Assurance Agreements with various contractors and vendors.
• Prepare recommendations to management for future budgets/supporting capital equipment procurement, installation and documentation.
• Other roles and responsibilities assigned by QC management.
Qualifications
• Bachelor’s degree with 5+ years of experience in Quality Control or Quality Assurance within the Pharmaceutical, Medical Device, or related industries.
• Proven experience in equipment/instrument/software validation, commissioning, and calibration.
• Excellent organizational, communication and collaboration skills.
• Self-motivated to learn and develop within the organization.
• Strong understanding of pharmaceutical regulations (cGMPs, FDA, ICH etc) required.
• Knowledge of 21 CFR Part 11 data integrity preferred.
• Hands on experience with equipment troubleshooting, operation or repairs preferred.
• Project coordination experience preferred.
