Senior Specialist, Quality Assurance:
Merck USA

Merck USA
Wilson North Carolina
Requisition ID: QUA007004

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. 

The primary responsibilities of the Senior Specialist, Quality Assurance include support of customer complaints and management of projects supporting customer complaints.

This Senior Specialist position must demonstrate solid leadership capability as demonstrated by, but not limited to, ensuring timely completion of customer complaints, establishing and maintaining knowledge and understanding of trends and changes within the production environment, as well as corrective action effectiveness. In addition, the Senior Specialist position must be proficient in Root Cause Analysis tools, technical writing and data analysis to identify trends associated with customer complaints. The Senior Specialist is knowledgeable in both domestic and international regulatory requirements, and ensures site compliance with all expectations. The primary roles and responsibilities may include:

  • Manages customer complaints and investigative activities which may span multiple sites. 
  • Independently manages projects associated with customer complaints and develops systems in support of new product introductions.
  • Challenges technical support and production groups to ensure robust root cause analysis and identification of corrective action. 
  • Creates/presents information to Senior level management to recommend the need for regulatory agency notification/market action. 
  • Authoring supporting documentation for Annual Product Reviews (APRs). 
  • Participates in policy development activity both locally and with MMD compliance experts externally. 
  • Interprets Merck Quality policies, GMPs, and other agency regulations for application to the Wilson site. 
  • Complaint and production investigation root cause analysis and corrective action identification. 
  • Interactions as SME with auditors/inspectors during internal/external GMP audits and regulatory inspections. 
  • Policy/procedure development and interpretation. 
  • Review and approval of GMP-related SOPs. 
  • Knowledge of equipment/process validation/qualification activities. 
  • Regulatory documentation review. 
  • Monitoring of performance through tracking and trending to ensure compliant operations. 
The Senior Quality Specialist may participate in or lead key compliance projects at the site aimed at elevating our compliance posture. Project Managers are expected to fully manage all aspects of assigned projects, including but not limited to: quality decision making, stakeholder management, issues identification and resolution, and drive all aspects of project in alignment with established timelines.

Specific Roles/Responsibilities:
  • Lead and facilitate compliance projects to support sustaining and/or enhancing compliance. 
  • Lead and facilitate compliance projects to support new product introductions.
  • Author complaint investigations for high risk customer complaints.
  • Support ad-hoc data requests and analysis.
  • Author, review, and approve procedures and other control documents associated with customer complaints. 
  • Present/discuss GMP deliverables as the SME with Domestic and International Regulatory Agency inspectors and auditors. 
  • Assist with aspects of Regulatory Inspections and commitments. 
  • Participate in internal audits and shop floor inspections. 
  • Performing and coordinating Product Quality Complaint activities. 
  • CAPA Management. 
  • Performing gap analysis and remediation. 
  • Conduct training on compliance topics. 
  • Execute projects as required by the Associate Director.


Minimum Requirements: 

  • Bachelor’s degree in science, engineering or related field. 
  • Minimum 8 years in pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality decision making responsibility.
  • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment. 
  • Demonstrated self-starter with capability to develop innovative solutions to challenges. 
  • Ability to deliver results through proven analytical aptitude, critical thinking skills, and ability to apply key concepts. 
  • Speaks with courage and candor. 
  • Strong written and verbal communication skills.
  • In-depth working knowledge and/or experience with medical device regulations and requirements.
  • Direct experience with managing or investigating customer complaints.
  • Direct experience supporting Regulatory inspections or audits

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 [email protected].


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.


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Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications