Instrumentation Manager
This is a 12-month contract opportunity to join our Instrumentation Group within the Quality Control Department.
The successful candidate will be responsible for managing and controlling the laboratory instrumentation calibration program, handling unplanned maintenance activities, and ensuring GMP compliance in all QC operations and documentation.
Key Responsibilities:
* Coordinate the calibration schedule in collaboration with vendors.
* Review calibration and qualification documentation for all laboratory instruments.
* Review reports related to unplanned maintenance and corrective actions.
* Manage changes to instruments, including relocations and decommissioning.
* Troubleshoot laboratory equipment and resolve technical issues.
* Oversee the purchase and qualification of new laboratory instruments.
* Manage instrument change controls to maintain compliance.
* Develop new SOPs and ensure all equipment-related procedures are up to date.
* Lead calibration investigations and implement improvements.
* Support the implementation, qualification, and routine maintenance of analytical instruments.
* Ensure GMP compliance in all QC operations and documentation.
* Manage relationships with suppliers, including new equipment and software solutions.
* Foster a culture of growth, enablement, and high performance within the team.
Requirements:
* Bachelor's degree in Analytical Science, Chemistry, or a related field.
* Minimum of 3 years of experience in the pharmaceutical industry.
* Strong understanding of Quality Control operations.
* Experience participating in regulatory audits with knowledge of FDA regulations, GMP standards, and their application to API manufacturing.
* Knowledge of equipment validation and change control procedures (desirable).
* Strong organizational and time management skills to manage multiple tasks, prioritize workloads, and meet deadlines for calibrations, maintenance, and testing.
* Ability to interact effectively with Quality Assurance (QA), Instrumentation Management (IM), and multiple vendors.
* Highly motivated team player with proven success in collaborative environments.