Edison-New Brunswick Metro Area, NJ
The ECQ LC Specialist supports the successful operation of Waters and Agilent HPLC, UPLC and LCMS systems through interaction with internal customers and external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems associated with HPLC, UPLC and LCMS systems. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization. The incumbent may be asked to lead small to medium sized projects in their area of responsibility, and will be called upon to create and revise work processes or procedures that impact their immediate function or organizational unit. The incumbent may be involved with writing deviations, investigations and supporting the implementation of change controls.
1) Operational Activities
a. Executes HPLC, UPLC and LCMS calibrations, maintenances, repairs, and requalification activities in laboratory areas.
b. Demonstrated proficiency for calibration, preventative maintenance, and qualification functions as related to Waters and Agilent HPLC, UPLC, and LCMS systems.
c. Coordinates/supervises LC vendors for calibration, preventative maintenance, and qualification functions.
d. Reviews and approves LC vendor executed calibration, maintenance, repair, and qualification records for accuracy, completeness and compliance to Celgene standards.
e. Works closely with, and enters data into the site CMMS system.
f. Ensures all LC calibration, PM, and qualification records are filed appropriately after approval.
g. Writes and supports deviations and investigations that result from LC qualification failures, if applicable, along with developing and supporting the implementation of corrective and preventative actions.
h. Support the development, revision and review of written LC procedures for calibration, preventive maintenance and requalification of equipment.
i. Support the development, review and approval of LC calibration and maintenance plans in site CMMS system.
j. Supports the execution of LC qualifications and process improvement studies.
k. Adheres to all policies and procedures which govern the ECQ team and the LC equipment they manage to ensure compliance is held to the highest standard.
BS in Engineering or Science related discipline preferred.
Minimum 5 years of experience performing qualification, maintenance and repairs of Waters and Agilent LC equipment in FDA-regulated industry required.
LC instrumentation background and experience in laboratory operations.
Knowledge of cGMP in the pharmaceutical industry.
Excellent computer skills including knowledge of calibration management.