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Laboratory Equipment Specialist

This position is responsible for assisting with administration of the Chromatography Data System (CDS) and other 21 CFR Part 11 compliant systems. Additional responsibilities include assisting with the purchase and qualification of new analytical equipment and software, troubleshooting and repairing equipment issues, and maintenance of equipment in the QC Laboratory.
Position Responsibilities: Provide user support for the Quality Control Laboratory regarding the CDS including adding new instruments, developing of methods and reports and assisting with daily system maintenance. Qualification of new and existing analytical equipment and instrumentation including any computer and the software/firmware required to control such equipment or instrumentation. Troubleshoot/repair instrumentation including coordinating with external vendors and maintaining equipment per governing procedures. Provide training on how to use the CDS and other instrumentation. Create, update and maintain validated Excel workbooks used within the laboratory. Performs other duties as assigned or requested.
Position Requirements:
Minimum Education
Bachelor's Degree in Chemistry, Engineering or another related field
Minimum Experience
1 year in a Pharmaceutical Quality Control analytical laboratory.
2 - 5 years in an analytical chemistry lab in a Pharmaceutical or similarly regulated environment
Minimum Field of Expertise
Ability to coordinate and manage multiple projects in a fast-paced environment.
Ability to solve complex issues and assignments independently with minimum supervision.
Ability to train and influence others to use new technology in the laboratory.
Attention to detail
Excellent Organizational and follow through skills
Excellent technical writing skills.
Excellent written and verbal communication skills.
Must be able to work well within a team environment
Preferred Experience
Knowledge of GMP's and 21 CFR Part 11
Knowledge of USP <1058> Analytical Instrument Qualification
Knowledge of Windows based networking and operating systems


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