JOB SUMMARY Perform scheduled services and advanced level troubleshooting/service of unscheduled work on specialty equipment, instruments and systems specific to the pharmaceutical Research & Development industry. Possess in-depth technical knowledge requirements for performing complex analytical service procedures, instrument qualifications and calibration tasks. Previous work in a GMP environment desired on tablet press and capsule making equipment. ESSENTIAL DUTIES and RESPONSIBILITIES Performs or oversees any in-house services required for instruments that are not currently covered by existing standard operating procedures/guidelines. Documents all work performed to ensure compliance with Good Manufacturing Practices (GMP), Good Lab Practices (GLP) and other applicable Food and Drug Association (FDA) regulations. Recognizes out of tolerance conditions and initiate corrective action and documentation. Assist in training other technicians. Performs calibration and functional checks using a combination of chemical, mechanical and electronic standards. Prepares chemical test standards per applicable Standard Reference Material publications (NIST or equivalent). Monitor standard viability and initiate corrective actions based on analytical evaluations. Performs advanced level repairs/upgrades/troubleshooting beyond what is accomplished during a routine calibration or preventive maintenance or service. Performs modifications to analytical equipment to make them more compatible with specific user defined applications. Develops and writes instrument procedures relating to calibration, calibration limits and interval assessment, preventive maintenance or other documentation for pharmaceutical R&D analytical services. Records and reports abnormal function of equipment or out of tolerance conditions and initiates corrective action. Assists in evaluating cost saving opportunities via internalization of tasks, part reconditioning, and changing vendors. Locates part sources, estimates costs and prepares requisitions. Communicates with customer staff and outside contractors in the calibration, repair and operation of equipment necessary and coordinates with outside contractors regarding repairs covered by maintenance agreements. Complies with company policies and procedures and adheres to company standards. Performs work in accordance with approved equipment calibration, maintenance and safety procedures. Overtime and emergency after hours work on Analytical lab equipment and related systems are required at times. Performs other duties as required. QUALIFICATIONS
SAFETY Complete all required and assigned HSE training at a satisfactory level Follow all activity policies and procedures, including all HSE-related requirements at all times Participate in all HSE-related programs & activities as required, including incident investigations, interviews, auditing and assessment, etc. Report any conditions which you feel could result in an accident or injury and / or stop work if required
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