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Site Internal Support Auditor - GMP

Elkton, VA

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Requisition ID: QUA007535Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified itsu00a0legacy for over a century. Mercku2019s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network thatu2019s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.u00a0Maintain current technical, compliance, regulatory, and audit skill knowledge to ensure audit program effectiveness through identification of early compliance warning signals. Lead by example and apply cutting edge, risk-based audit techniques. Effectively communicate audit/inspection results to stakeholders and site leaders. Evaluate root cause analysis, corrective and preventative (CAPA) responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation. Support the preparation and hosting Health Authority inspections and Divisional GMP Audits. Generate and report metrics / trends for program adherence to requirements and effectiveness. Key Responsibilities: Lead and perform site internal audit program for system and walk-through audits for all site operationsPerform foru2013cause audits, review/approval of CAPA responses (including root cause analysis), and CAPA verification/effectiveness checksCollaborate with auditors at Divisional and Site level to maintain cutting edge compliance/regulation/auditing skillsGenerate observations and propose ratings, and overall audit outcome ratingu00a0Participate in change and process initiatives related to audits, inspections, and CAPAu00a0Achieve and maintain auditor expertiseu00a0Actively participate in the Auditor Community of Practice and Guest Auditor Program at the Divisional levelQualificationsEducation Minimum Requirement: Bacheloru2019s Degree in Engineering, Biology, Chemistry or related fieldRequired Experience and Skills:u00a0 Minimum of 4 years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environmentParticipation in GMP Auditing in the Pharmaceutical industryKnowledge of US and European cGMP guidelines, ICH and other international regulatory requirements, as applicable to the site.u201cSubject Matter Expertiseu201d, including knowledge and demonstrated application in one or more of the following areas: Biologics, Vaccines, Sterile Drug Product, APIsSpecific technical knowledge in Deviation Management, Change Control, Manufacturing, QC & Stability Testing, Microbiological testing, Distribution, Data Integrity, Automation)Experience with TrackWise software systemsLearning agility u2013 demonstrated ability to continually learn new technical, quality/compliance, & regulation knowledge and applyu00a0Act with Courage and Candor u2013 demonstrated ability and willingness to advocate for compliance position using objective evidenceCollaboration u2013 ability to maintain productive communication channels with stakeholdersExcellent verbal and written communication skillsPreferred Experience and Skills:Experience with leading and performing effective audits and obtaining meaningful audit observationsProblem-solving / critical thinking u2013 ability to understand connections between different technical/quality system areas and recognize potential compliance issuesKnowledge of and experience in Quality Risk Management methodsExperience with hosting or participating in Health Authority inspections and/or Divisional auditsAbility to prioritize and balance work from multiple projects in parallelYour role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and weu2019re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, weu2019re inventing for life.u00a0u00a0If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request ****. u00a0u00a0Search Firm Representatives Please Read Carefully:u00a0Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.u00a0 Please, no phone calls or emails.u00a0 All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.u00a0 No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.u00a0Visa sponsorship is not available for this position.u00a0For more information about personal rights under Equal Employment Opportunity, visit:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0EEOC Posteru00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0EEOC GINA Supplementu00a0Job: Quality OperationsOther Locations: Employee Status: RegularTravel: Yes, 5 % of the TimeNumber of Openings: 1Shift (if applicable): Hazardous Materials: Company Trade Name: Merck,employmentType:[,OTHER],title:Site Internal Support Auditor - GMP,url:****States,postalCode:22827}},hiringOrganization:{@type:Organization,name:Merck,logo:****{@context:****Internal Support Auditor - GMP}}]}

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