Validation Specialist 3

Job Description

Job Location: Allston, MA (System Correction)

QC Instrumentation Services is responsible for the management and implementation of the Laboratory Equipment Qualification system.

It's goal to efficiently specify/source laboratory equipment and execute qualifications in a timely manner to enable QC Microbiology and QC Chemistry departments to execute their functions using equipment which meets their needs and intended use.

These are some of the responsibilities:

Coordinate activities relating to the qualification, calibration and maintenance of laboratory equipment and related systems. Coordinate the purchase, commissioning and introduction to service of new equipment. Establish and maintain Equipment History Files (EHF) for QC laboratory equipment. Be the contact point for instrumentation issues and provide training and troubleshooting support to the laboratory on new or existing instrumentation. Coordinate all services provided by vendors, ensuring vendors meet all site requirements. Schedule/plan/execute validation activities and preventive maintenance of laboratory equipment.

Skills:

Demonstrated scientific technical writing ability.

Knowledge of USP 1058 and GAMP methodology.

Knowledge of 21CFR Parts 11, 210, 211, 600 and 610.

Experience with Empower and LIMS systems.

Previous hands on experience performing laboratory equipment qualification.

Proficient in Outlook and Microsoft Word and Excel and lab based data management systems.

Ability to gown and enter laboratory

May require off shift work to support activities

Ability to gown and enter laboratory

May require off shift work to support activities

Qualifications

Bachelor's Degree in Chemistry, Life Sciences, or Engineering discipline and 5 years of Industry relevant experience

Or

Master's Degree in Chemistry, Life Sciences, or Engineering discipline and 3 years of Industry relevant experience

Minimum of 3 years of experience with analytical testing in a laboratory setting, such as HPLC, GC, Ion Chromatography, TOC, UV-Vis, ELISA.

Additional Information

Best Regards,

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960