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Job Details

Site Internal Support Auditor - GMP

Location
Elkton, VA

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Requisition ID:
QUA007535

Merck & 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 its 
legacy for over a century
. Merck’s 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 that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. 
Maintain 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 operations
Perform for–cause audits, review/approval of CAPA responses (including root cause analysis), and CAPA verification/effectiveness checks
Collaborate with auditors at Divisional and Site level to maintain cutting edge compliance/regulation/auditing skills
Generate observations and propose ratings, and overall audit outcome rating 
Participate in change and process initiatives related to audits, inspections, and CAPA 
Achieve and maintain auditor expertise 
Actively participate in the Auditor Community of Practice and Guest Auditor Program at the Divisional level
Qualifications
Education Minimum Requirement:
Bachelor’s Degree in Engineering, Biology, Chemistry or related field
Required Experience and Skills:
Minimum of 4 years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment
Participation in GMP Auditing in the Pharmaceutical industry
Knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements, as applicable to the site.
“Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas: Biologics, Vaccines, Sterile Drug Product, APIs
Specific technical knowledge in Deviation Management, Change Control, Manufacturing, QC & Stability Testing, Microbiological testing, Distribution, Data Integrity, Automation)
Experience with TrackWise software systems
Learning agility – demonstrated ability to continually learn new technical, quality/compliance, & regulation knowledge and apply 
Act with Courage and Candor – demonstrated ability and willingness to advocate for compliance position using objective evidence
Collaboration – ability to maintain productive communication channels with stakeholders
Excellent verbal and written communication skills
Preferred Experience and Skills:
Experience with leading and performing effective audits and obtaining meaningful audit observations
Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues
Knowledge of and experience in Quality Risk Management methods
Experience with hosting or participating in Health Authority inspections and/or Divisional audits
Ability to prioritize and balance work from multiple projects in parallel
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to
  ****
Search Firm Representatives Please Read Carefully: 
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  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.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
             EEOC Poster
             EEOC GINA Supplement 
Job:
Quality Operations
Other Locations:
Employee Status:
Regular
Travel:
Yes, 5 % of the Time
Number of Openings:
1
Shift (if applicable):
Hazardous Materials:
Company Trade Name:
Merck
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