Job DescriptionOur 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.Position De for providing functional support for Analytical Standards and Analytical change control activities for new products, in-line products, packaging, outsourcing, divestitures and compendial compliance. Partners with change control initiator/owner and various stakeholders in Regulatory, Technology, Supply Chain, Operations, and Quality to coordinate assessment and approval of analytical change controls.  Ensures alignment across subject matter experts and stakeholders to implement analytical changes globally.  Operates in a complex business environment with significant regulatory complexity.Assists in escalating change control issues and works with our Manufacturing Division network to remove bottlenecks to ensure on time delivery of the change. Coordinates resolution of misaligned change control priorities across operating units within Small Molecules. Performs appropriate document review and change control quality approval activities associated with their position and ensures change control is in compliance with all regulatory and current Good Manufacturing Practices expectations.Ensures that Analytical Standard documents are written clearly and unambiguous, are maintained in accordance with established divisional and departmental procedures, and issued in a timely fashion.  Maintains active ingredient, intermediate, raw material, incipient, component and final product global specifications. Performs appropriate document review and change control quality approval activities associated with their position and ensures change control is in compliance with all regulatory and current Good Manufacturing Practices expectations.Participates in activities and interactions of interest to our Company in regard to the compendia.  Provides review of proposed and official compendial publications and collaborates with compendial stakeholders to determine path of implementation for compendial updates.Proceeds independently on his/her knowledge of change control, carrying full responsibility for the implementation of the appropriate scientific principles, procedures, and divisional guidance. Escalates issues as appropriate.  Imparts creative thinking, the development of original concepts, and resourcefulness for a high level of performance and achievement for the organization.Ensures appropriate level of support and service is provided to all customers and business stakeholders.  Exercises the utmost professional objectivity and integrity in reporting findings and interacting with others.  Proficient in recognizing and dealing with conflicting issues, and the ability to build consensus. Maintains a broad based knowledge of Good Manufacturing Practice. Our Company Policies, Procedures and Guidelines, regulatory requirements, compendial requirements, etc. pertinent to the manufacturing, personal safety, control, testing and documentation of pharmaceutical products.  Maintains awareness of evolving industry and regulatory trends and seeks opportunities to influence direction.  Demonstrates continuous improvement through the ability to optimize functional performance and teamwork through the relentless pursuit and application of standards, best practices, appropriate tools, to positively impact individual and organizational performance, quality, and outcomes for delivery of value and competitive success.Education Minimum Requirement: BS degree required, concentrations in life sciences, engineering or related relevant disciplineRequired Experience and Skills: Minimum of 5 years applied professional work experience working in one or more of the following areas: Change Control, Laboratory Operations and/or Quality operations with laboratory oversight. Strong technical knowledge and high level of technical performanceUnderstanding our Manufacturing Division change control environment and systemsAbility to lead/work well in teams, managing multiple projects/tasks simultaneously with competing prioritiesStrong collaborative and communication skillsPreferred Experience and to lead/work well in teams, managing multiple projects/tasks simultaneously with competing prioritiesStrong collaborative and communication skillsSuperior written and oral communication skillsAdvanced problem solving and proficient decision making skillsProficient computer skillsOur Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time. Who we are … Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.What we look for … 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.INVENT.IMPACT.INSPIRE. NOTICE FOR INTERNAL APPLICANTSIn 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.If 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.If you need an accommodation for the application process please email us at more information about personal rights under Equal Employment Opportunity, PosterEEOC GINA Supplement​OFCCP EEO SupplementOFCCP Pay Transparency RuleWe are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read Carefully Merck & 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. Employee Status: RegularR relocationVISA Sp Req Work Arr :Valid Driving Material(s):Number of Openings: 1
Full time

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