Specialist, Quality Control

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Location :
Wilson, North Carolina

Expiry Date :
Sun, 28 Mar 2021 23:59:59 GMT

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Description :
Job Description nThe Specialist is an integral position for our worldwide Stability Laboratory that reports to the Stability Laboratory Manager. The position is accountable for management of stability samples for the site stability program and for external sites that send samples to NASU-Wilson to be placed on stability. Accountable for establishing stability studies, placing samples in chambers and pulling stability samples for laboratory testing within the required time frames set forth in our Company guidelines n Responsibilities nReceives annual stability plan from other sites and ensures that stability samples and related documentation are received accordingly nAccountable for management of projects, obtaining stability samples and starting stability studies nProvides API sample material, labels and documentation to API chemists for subdivision nAccountable for writing study protocols based on the General Stability Protocol nRemoves extraneous secondary packaging on samples as needed; prepares and affixes stability sample labels on samples, stores samples in stability chambers and records inventory information in LIMS nMaintains stability sample inventory information in SQL/LIMS | Discards samples for concluded and terminated studies nCreates, updates and maintains stability study files nDevelops/revises SOPs based on our Company policies/guidelines nAssists with laboratory investigations and integrates appropriately personnel into investigation meetings to determine root cause and path forward nEducation Requirement nBachelor degree (Science Degree, i.e. Chemistry, Biology, or Engineering) nExperience and Skills nRequiredn Minimum three years pharmaceutical industry nKnowledge of cGMPs, NDA, related regulations nComprehension of documentation systems nStrategic and effective verbal and written communication nPreferredn Flexibility nMotivation nFunctional excellence nTeamwork/Partnership nResults-Oriented nProblem-Soving nCommunication nWilsonQuality 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: n10% nFlexible Work Arrangements: nFlex Time nShift: n1st – Day nValid Driving License: nNo nHazardous Material(s): nYes – OEB 3, 4, 5 compounds nNumber of Openings:n 1 nRequisition ID:R