Merck Specialist, Quality Assurance in West Point, Pennsylvania

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.

This position within the Quality Assurance IT (QA IT) group is looking for an ambitious indvidual to help us define the future of the Laboratory Systems team for the Merck Manufacutring Division (MMD) within Global Quality (GQ).

In this role, your focus will include:

  • Collaboration with MMD business functions & IT to asses/select/implement innovative technology solutions and upgrade existing solutions driving efficiency & compliance for global Good Manufacturing Processes (GMP) and GXP lab systems in human health

  • Drive resolution to regulatory non-conformance of GMP Lab systems (both internal & external)

  • Maintain/update/enhance System Development Lifecycle (SDLC) processes & IT controls for GMP Lab systems

  • Lead workstreams for validation strategy for creation visible dashboards for data trending

To be successful in this role, which works with a diverse slate of customers across organizations globally, both strong technical skills and interpersonal skills are critical. Therefore, you should possess the following traits:

  • A strong QA IT background with understanding of the use and validation of laboratory systems from the end-users perspective

  • Experience performing SDLC activities on standalone systems within the laboratory and/or applications such as GLIMS

  • The ability to proactively recognize and mitigate barriers to cross-functional initiatives and act as an intermediary across divisional, geographical, and cultural boundaries

  • Promote a culture of continuous improvement and respectfully challenging the status quo, while driving departmental/regional strategies that align with Merck’s long term strategy

  • Build trust and develop new relationships with internal and external clients to effectively collaborate and achieve successful outcomes at a regional/global level

Education Minimum Requirement:

  • Bachelor’s Degree in a science or engineering discipline or related field

  • A minimum 5 years' experience in the QA IT industry with understanding of the use and validation of laboratory systems from the end-users perspective

  • Hands-on experience and understanding of major Lab Systems (like NuGenesis, LIMS, Empower, LabWare, Nucleus etc.) supporting pharmaceutical QC/QA/manufacturing operations

  • Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820

  • Previous experience in qualification and use of IT laboratory systems, such as LIMS, standalone instruments, etc.

Preferred Experience and Skills:

  • Training in GAMP 5 (Good Automated Manufacturing Practice)

  • Ability to accurately interpret and apply regulatory expectations to SDLC documents

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 .

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Visa sponsorship is not available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Qual Assurance & Ops Generic

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Title: Specialist, Quality Assurance

Primary Location: NA-US-PA-West Point

Requisition ID: QUA007511