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Laboratory Systems Administrator

Company: Piramal Pharma Solutions
Location: Taylor
Posted on: November 22, 2022

Job Description:

*POSITION SUMMARY: *Piramal Pharma Solutions' HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Laboratory Systems Administrator to join our Quality function. The Laboratory Systems Administrator is responsible for the administration and coordination of laboratory system software to meet end-user needs and regulatory expectations (21 CFR Part 11 and cGMP), and established SOP's.*_To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required: _* - Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices. - Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values. - Identify and protect the original technical information as part of the company property.*Key responsibilities. * - As an integral member of the Laboratory Information Management System (LIMS) implementation team, manage the deployment, set-up, configuration (creating workflows, analytical test methods, and analytical specifications), validation (IQ/OQ/PQ, validation plans, user requirements, risk assessments, using GAMP requirements), and execution of test scripts for the LIMS system. - Perform all duties as LIMS administrator, on-going configuration and improvements, develop custom reports, troubleshooting, and maintenance in conjunction with IT. - Administer analytical laboratory software systems, including the Chromatography Data System (CDS) for GC, GCMS, HPLC, and LCMS systems and Agilent Enterprise Content Manager (ECM) for back-up and archiving of analytical data. - Collaborate with vendors on upgrades and improvements. Install and validate new software revisions as they are released. Partner with the ASI laboratory staff for troubleshooting. - Lead and coordinate technical issue investigations and manage technology resolution implementations. - Actively participate on change control by following procedures and work instructions. - Develop SOP's and policies for laboratory computer and LIMS applications. - Stay up to date on advances in the software and technology; provide appropriate training to new and current employees as needed.*EDUCATION/EXPERIENCE. * - Bachelor's degree in Chemistry or life sciences. A minor in computer sciences is helpful. - Three (3) to five (5) years' experience in laboratory operations, LIMS administration, chromatography data systems, or equivalent training and experience. - Knowledge of data integrity concepts, cGMP, 21 CFR Part 11, and computer system validation (GAMP) is a plus.*job competencies. * - Excellent written and oral communication. Present and train relevant information to all levels within the company. - Ability to adapt to and thrive in a dynamic work environment and cooperate with employees and clients from a broad range of disciplines and subject-level expertise. - Proficiency in computer applications (Microsoft Office, ERP, etc.). - Demonstrated ability to multi-task on ongoing projects and tasks.*job conditions.**_The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions._* - *_Physical Demands_*_: _o Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.o Long periods of standing and walking can be expected in this position.o This position may require long periods of sitting, typing, computer entry or looking at a computer. - *_Work Environment_*_: _o Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes.o Potential limited exposure to hazardous chemicals.o Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.Job Type: Full-timeBenefits:* 401(k)* Dental insurance* Health insurance* Paid time off* Vision insuranceSchedule:* 8 hour shiftExperience:* LIMS: 1 year (Preferred)* Tiamo: 1 year (Preferred)* Agilent: 1 year (Preferred)Work Location: One location

Keywords: Piramal Pharma Solutions, Taylor , Laboratory Systems Administrator, IT / Software / Systems , Taylor, Michigan

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