Merck Senior Specialist, Quality Assurance Computer Systems Validation in Madison, New Jersey
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’s Animal Health (MAH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.
The Senior Specialist is responsible for ensuring a current, compliant and efficient quality management system for Merck Animal Health IT systems in US and EU Research and Development Division. This person will also be required to continuously pursue system improvements to optimize the IT QA processes in accordance with current regulations and guidelines.
The Senior Specialist, Quality Assurance –Computer Systems Validation (CSV) will be responsible for providing Quality leadership and support as the Quality Assurance liaison for IT system assessments, validation, change control, process improvements and compliance governance at all applicable points of the System Development Lifecycle (SDLC). This individual will represent Quality on IT projects in support of the SDLC activities, consult on the authoring and conformance of SDLC deliverables and activities in regard to procedures, policies and current regulations, provide QA oversight for system related issues, and employ risk-based methodology. Additionally, the individual will focus on ensuring consistent policy administration, implement key improvement initiatives and solve compliance issues in partnership with business owners.
Education Minimum Requirement:
- BA/BS required with a preference in an IT or scientific related discipline
Required Experience and Skills**:
3 years working in a Quality Assurance IT Role
Solid understanding of GLP/GMP/GCP and 21 CFR Part 11
Experience with computer system validation (CSV) across GXP landscape and system development life cycle ( SDLC)
Preferred Experience and Skills:
Pharmaceutical experience preferred
Experience conducting internal audits or vendore audits is a plus
General knowledge of software and database concepts of systems within an analytical and bioanalytical setting
Ability to provide support during regulatory authority inspections
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.
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Visa sponsorship is not available for this position.
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Job Regulatory Affairs Generic
Title: Senior Specialist, Quality Assurance Computer Systems Validation
Primary Location: NA-US-NJ-Madison
Requisition ID: REG004102