Specialist, Quality Assurance | Environmental Monitoring

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Location :
West Point, Pennsylvania

Expiry Date :
Fri, 26 Mar 2021 23:59:59 GMT

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Job Description nAre you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! nOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. nThe Environmental Monitoring Quality Specialist (EMQS) provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. With guidance from the EM Lead, the EMQS ensures product/process quality and performs activities to facilitate the release of product to the marketplace and is responsible for the review and evaluation of routine and per process environmental monitoring (EM) sampling of classified areas and utilities. This position also works closely with the assigned End to End (E2E) in a team environment to ensure timely completion of responsibilities with emphasis on right first time. nThe EMQS will become knowledgeable in Federal and other regulatory agency requirements and GMPs to assure that all areas operate in a state of compliance, and will train on and gain competency in their responsibilities for assigned End to End (E2E). Becomes fully trained in our Company Quality SOPs, production SOPs as needed, and SAP functions as required by EM Quality Specialists. Job functions are performed primarily on the production shop floor or at desk and in a team environment. Cross trains to support other functional quality areas including but not limited to deviation management for environmental monitoring investigations, and inspection support. Supports Process Simulations as a Quality Aseptic Observer . nResponsibilities nLearns cGMPs, the manufacturing process, and our Company quality systems nMonitor environmental performance against specifications within classified areas nProvide environmental support to manufacturing and testing areas as needed nPerforms Quality review/approval of new and updated SOPs and Controlled Job Aids nEnsures compliance with departmental procedures nActively participates in the Tier process and uses this forum to escalate concerns and best practices nCollaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans nAdherence to SOPs, GMPs and safety procedures nAid in investigations into environmental excursions nAuthor environmental project protocols and reports nAssists with training of incoming personnel nEducation Requirement nBachelor degree nOur Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time. nWho we are .n We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. nWhat we look for .n In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth. nInvent. Impact. Inspire. nNOTICE FOR INTERNAL APPLICANTS nIn accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. nIf you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. nUS and Puerto Rico Residents Only: nIf you need an accommodation for the application process please email us at nFor more information about personal rights under Equal Employment Opportunity, visit: nEEOC Poster nEEOC GINA Supplementn OFCCP EEO Supplement nOFCCP Pay Transparency Rule nWe are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations. nSearch Firm Representatives Please Read Carefully nMerck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. nEmployee Status:n Regular nRelocation: nNo relocation nVISA Sponsorship: nNo nTravel Requirements: nNo Travel Required nFlexible Work Arrangements: nNot Specified nShift: n1st – Day nValid Driving License: nNo nHazardous Material(s): nNone nNumber of Openings:n 1 nRequisition ID:R