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Senior Specialist, Quality Assurance - Information Tech

Company: Merck
Location: Durham
Posted on: May 15, 2022

Job Description:

?Job Description?New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law,?to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in customer facing commercial or research based roles, will be required to be fully vaccinated as a condition of employment.?Our 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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.?We are seeking a diverse, growth and improvement minded Quality Assurance Senior Specialist that can help drive our Strategic Operating Priorities:Invent?-?Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical NeedsExecute?- Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)Adapt?-?Develop Our People, Culture and Business Model to Evolve with a Dynamic LandscapeDiverse Talent?- We are dedicated to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world.Values and Standards?- Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success ? They are a Competitive Advantage for Us.?Key ResponsibilitiesStakeholder Partnership (System Owners - Process Owners - Data Owners - Technical Unit)Assess and select computerized systems which enable GMP business processesEnsuring Technologies selected meet the high-level business needs while encouraging innovation and efficiencyInteract with?our Manufacturing Division?IT and other internal and external entities to align GMP shop-floor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectivesEnsuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work?Key ResponsibilitiesProviding the independent quality approval of key qualification/validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations)Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans)Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effectiveSupporting regulatory inspection and audit activities which includes the review of audit or inspection reports, replying to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP complianceDriving resolution of regulatory non-conformance for GMP computerized systemsMonitoring and conveying system health, compliance and other metrics updates to key stakeholdersPromoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practicesRepresenting QA IT management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issuesContribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systemsMentoring, training and developing QA IT Specialist?EducationBachelor degree - Preferably in Science, Information Technology, Engineering or equivalent?RequiredDirect experience and comprehension of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operationsFive years in a regulated pharmaceutical manufacturing industryThree years delivering validated IT solutions or an application support role in a regulated environmentStrong comprehension of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectationsExtensive knowledge of the principles, theories and concepts of computerized system validation/complianceFamiliarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environmentLimited supervision required in day-to-day activitiesInclusion behaviors - Listening, integrating diverse perspectives, adds value to the achievement of team goalsWork independently and as a Team member with Integrity - Precision - Accomplishment - Motivational AmbitionPrincipled verbal and written communications including persuading others and developing cross functional relationships both at site and across sites?PreferredProfessional Certifications (e.g. Six Sigma or certification in Project Management (PMP)Operate as part of a self-directed team in carrying out day to day functions and assigning prioritiesGood understanding of applicable Engineering and/or Laboratory or Standards related to computerized systems development, implementation & OperationsDirect experience in a Quality and/or Compliance role in a GMP environmentBusiness engagement skills, with ability to collaborate with both technical and non-technical rolesLeading conversation during regulatory inspectionsAnalytical Problem solving skills applied to issue identification and resolutionTimely decision makingProject management skills combined with a since of urgency and a proven history producing quality deliverablesAbility to respond to changing prioritiesCoach and develop othersOur 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 ?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.?What we look for ?Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us?and start making your impact today.?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:Regular?Relocation:Domestic?Travel Requirements:10%?Number of Openings:1?Requisition ID:R166725

Keywords: Merck, Durham , Senior Specialist, Quality Assurance - Information Tech, Other , Durham, North Carolina

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