Quality Specialist, QSIP:

Durham North Carolina
Requisition ID: QUA006847

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. 

Reporting to the Associate Director, QSIP Project Management, the Specialist, QSIP, has primary responsibility for supporting Quality System Improvement Plan (QSIP) workstream deployment at the Durham site. As an integral member of the site QSIP deployment team, the successful candidate will assist workstream leads to build and/or improve the site-wide Quality Management programs in accordance with initiatives driven by the Divisional QSIP project. This role will require working cross functionally with Operations, Technology, Supply Chain, and Quality on both the global and local level.

Primary Roles include, but are not limited to:
•Works in an empowered, self- directed culture with a moderate level of guidance and direction.
•Assists with enhancement initiatives including identification, development and deployment of assigned improvement projects at the site level.
•Assists with workstream project management.
•Assists workstream leads in process mapping facilitation and documenting maps into electronic format.
•Assists SMEs in collating comments, updating, reviewing, and approving site or global procedures.
•Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.
•Active member of the Divisional Quality System Improvement Plan (QSIP) project(s).
•Represents site interests on network Quality System project teams.
•Analyzes and solves problems using standard problem solving processes.
•Performs special quality projects / investigations as requested by Senior Quality Management.
•Other duties as requested by Quality management.



B.S., B.A. degree in Science, Engineering, Business or Humanities

•A minimum of 5 years of leadership experience including a minimum of 4 years in GMP environment
•Understanding of FDA regulations/guidance
•Experience with improvement processes
•Strong analytical and problem solving skills
•Effective communication skills (both written and oral)
•Strong customer service focus

•Lean Six Sigma certification
•Experience with global projects

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.


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Visa sponsorship is not available for this position.


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Job: Quality Operations
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