GMP Site Auditor:
Merck

QUA006856-en_US
Merck
Danville Pennsylvania
Pharmaceutical
Description
Requisition ID: QUA006856

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. 


Lead and perform internal audits (system and walkthrough) at the MSD site. Maintain current technical, compliance, regulatory, and audit skill knowledge to ensure audit program effectiveness through identification of early compliance warning signals. Perform audits at regional MSD sites, and host regional guest auditors (as applicable). 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, 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
  • Generate annual audit schedule using risk-based principles
  • Perform for–cause audits, review/approval of CAPA responses (including root cause analysis), and CAPA verification/effectiveness checks
  • Perform audits with guest auditors from other MSD sites; participate in opportunities to audit at other MSD sites
  • Collaborate other 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 
  • Generate risk communication for Site (Quality Council)
  • Achieve and maintain auditor expertise 
  • Generate metrics for audits, inspections, and CAPAs; propose any remediation required
  • Generate annual audit/inspection performance report 
  • Actively participate in the Auditor Community of Practice and Guest Auditor Program at the Divisional level

Qualifications

Education: 

  • Bachelor’s Degree in Engineering, Biology, Chemistry or related field

Required:

  • Minimum of 6 years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment
  • Knowledge of US, 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, based on site activities: Medical Device/Combination products, Biologics, Vaccines, API's or Non Sterile or Sterile Drug Product
  • Specific technical knowledge in areas pertaining to the site (e.g, Quality Systems, Manufacturing, Testing/Stability, Microbiological testing, Data Integrity, Automation)
  • 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:
  • GMP Audit experience in the Pharmaceutical industry
  • 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 QBD development & submission requirements, as applicable to site
  • 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 staffingaadar@merck.com.

  

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: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement