CSV QA Analyst - Rahway New Jersey

Company: Insight Global
Location: Rahway, New Jersey
Posted On: 04/26/2024

Our Biopharmaceutical client is seeking a CSV QA Analyst to join their team in Rahway, NJ. This individual will lead Quality Assurance oversight for computer system validation matters within the Global Development Quality Organization. They will act at the quality unit representative for the clinical supply group for IT products such as infrastructure, business applications, shop floor automation systems and standalone, laboratory instrument systems. They will promote and build Quality Management System elements into the end-to-end computer system validation process, thereby promoting permanent inspection readiness. This individual will consult, assess and assist with risk based, tailored approaches for computer system validation activities and testing. They will 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. They will 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 and 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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Required Skills & Experience
- B.S. and/or M.S. degree in an appropriate Life Science, Computer Science, Information Technology or Engineering discipline
- 5+ years of experience in pharmaceutical/biotechnology industry
- experience in a regulated environment
- 5+ years of CSV, SLC, and QA 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.

Nice to Have Skills & Experience
- Experience with calibration and qualification
- Expertise with configuration management
- Some level of experience with IT Infrastructure Language and service management

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law. More...

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