Merck Senior Specialist, Quality Assurance in Branchburg, 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 is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Responsibilities include but are not limited to:
• As a member of the Merck Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality organization.
• For Merck Clinical Supply, act as the Quality Unit representative for information technology products such as infrastructure, business applications and standalone, laboratory instrument systems.
• Promote and build Quality Management System elements into the end-to-end computer system validation process, thereby promoting permanent inspection readiness.
• Develop and maintain a subject matter expert level of understanding for the Merck Policies, Procedures and Quality Manuals governing computer system validation activities.
• Consult, assess and assist with risk based, tailored approaches for computer system validation activities and testing.
• Provide independent Quality Assurance oversight for the implementation of new computerized systems, change control involved with existing computerized systems as well as the retirement of computerized systems in the Clinical Supply domain.
• Develop and maintain an overall computer system validation posture and program for a defined functional area(s) (single point of contact) within Clinical Supply, including support for System Development Life Cycle deliverables and testing.
• Act as a liaison with respect to the Quality Management System and Compliance pillars of Global Development Quality for the purposes of investigations, corrective action/preventive action, procedural controls, auditing and Quality Risk Management.
• As required, participate in Regulatory Agency inspection activities.
• Deliver stewardship for Merck corporate initiatives from a Quality Assurance perspective, such as the Data Integrity and Enterprise Resiliency programs.
• Identify and incorporate continuous improvements into computer system validation activities and standards. Leverage external affiliations in order to evaluate current trends.
• Collaborate and establish relationships with key stakeholders in the Business and Technical Units, including external suppliers.
Education Minimum Requirement:
• B.S. and/or M.S. degree in an appropriate Life Science, Computer Science, Information Technology or Engineering discipline.
Required Experience and Skills**:
• Experience working in a Pharmaceutical/Biotechnology industry; experience working in a health authority regulated (e.g. GxP) environment.
• Minimum of 5 years of industry experience including computer system validation, System Life Cycle (SLC), software validation, and/or Quality Assurance functions.
• High level of expertise and exposure with agency regulations, such as 21 CFR Part 11, Part 58, Part 210, Part 211 from the US Food and Drug Administration.
• High level of expertise in SLC methodology (e.g., V-model, waterfall, agile, spiral) including change management.
• Extensive experience providing oversight for adherence to enterprise SLC and procedures.
• Proficient skills dealing with and understanding typical laboratory facilities and equipment.
• Ability to prioritize and manage multiple initiatives, projects concurrently.
• Excellent interpersonal skills including ability to work as a team member in a collaborative environment.
• Excellent written and communication skills including thorough knowledge of Good Documentation Practices.
• Possess excellent time management skills.
• High attention to detail.
Preferred Experience and Skills:
• Experience with calibration and qualification.
• Expertise with configuration management.
• Knowledge of published regulatory agency data integrity guidance.
• Moderate level of experience with electronic tools such as software providing document management and testing capabilities.
• Some level of experience with IT Infrastructure Language and service management.
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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Job Clinical, Non Clinical Quality Assurance
Other Locations: NA-US-NJ-Rahway, NA-US-NJ-Kenilworth, NA-US-PA-West Point
Title: Senior Specialist, Quality Assurance
Primary Location: NA-US-NJ-Branchburg
Requisition ID: CLI008221