Laboratory Equipment Specialist II

ROLE SUMMARYThe QC Specialist-Lab Equipment serves as a key contributor to manage the Quality Control Chemistry laboratories equipment maintenance program. Primary responsibilities for this role include performing Calibration and Preventive Maintenance (PM) of laboratory equipment including unscheduled maintenance and service; conducting the out of tolerance/laboratory investigations; conducting periodic reviews and providing or coordinating training on the laboratory equipment and related system software applications. The QC Specialist (Lab Equipment) will work under general supervision referring to policies and practices for guidance and follows established procedures. The incumbent operates within established HR policies and basic colleague relations guidelines and contributes to the completion of specific team objectives and assigned project milestones. The successful candidate will be required to drive continuous improvement and maintain a state of regulatory audit readiness over these programs and will demonstrates knowledge and leadership QC Specialist (Lab Equipment) also serves as a System Administrator of standalone laboratory computer applications ensures appropriate Calibration and PM of laboratory equipment to use in the respective areas and determines when equipment requires recalibration. He/she provides technical support to the laboratories for the selection/evaluation of new equipment and action items implementation from trending Kindeva Quality Standards and Compliance Analysis Status reports evaluates changes for validated/qualified laboratory equipment or laboratory facilities and is responsible for approving new or modified Calibration/PM acceptance criteria that impacts the safety identity strength or quality of the product (e.g. validation and/or regulatory commitments. Additional responsibilities will include authoring and supporting SOP revisions change control requests reviewing validation/qualification protocols technical reports project plans trend reports equipment Calibration/PM and procedures RESPONSIBILITIESPerforms the equipment Calibration/Verification or PM according to the established the Calibration/Verification or PM data to ensure that the equipment is calibrated according to predetermined schedules and Calibration/Verification or PM records including certificates of standards along with calibration due calibration standards or Test Equipment to support the updated records of the Calibration or PM service contractor and approves contractors all laboratory equipment procedures are aligned with the current compendia (such as USP/NF EP or any other regulatory reference) equipment owner and Quality Assurance of any discrepancy found during maintenance or Laboratory Equipment Master List is maintained and inspection and evaluates data in terms of accuracy precision trends and potential cGMP impact and recommends appropriate corrective existing techniques and procedures with recommendations and implements modifications for improve laboratory efficiency and and support laboratory equipment a complete understanding and wide application of pharmaceutical industry functional and specific principles theories concepts and practices. Focus on leading/overseeing defined processes that may require detailed determines and develops approach to solutions provides solutions to a wide range of difficult/complex problems as well as identifying cause and effect duties within the quality department as QUALIFICATIONSBachelor of Science- Chemistry5 years previous experience in pharmaceutical laboratory operation and laboratory equipment maintenance; operation/calibration/preventative maintenance and leadership are highly desirableKnowledge of 21 CFR 210/211The incumbent must understand the working principles of common simple and complex laboratory equipment be familiar with special analytical techniques understand and implement procedures pertinent to laboratory operation/calibration/PM programExcellent analytical and investigation skillsExperience with Empower Chromatographic data system application and instrument specific software in English both speaking and writingPREFERRED QUALIFICATIONS:The successful candidate will have good planning skills good oral written and interpersonal communication skills and basic computer literacy and demonstrate the ability to organize time independently and prioritize candidates will possess expertise of analytical laboratory techniques laboratory equipment operations/calibration/PM compendia requirements chromatography technique Empower chromatographic data system and technical written utilizing Lean Six Sigma and other continuous improvement methodologies for process improvement is highly desirable.#LI-Onsite