This job listing has expired and the position may no longer be open for hire.

Computer Systems Validation Analyst at Advanced Resources in Raleigh, North Carolina

Posted in Other 30+ days ago.

Type: Full Time





Job Description:

JOB DESCRIPTION

* Responsible for ensuring systems comply with data life cycle requirements from initial data creation/recording to archival and decommissioning. This includes, but is not limited to, data management (e.g., data creation, data processing, re-processing, review, reporting), data security, data traceability/process mapping, data backup/restore, electronic signature/electronic record linking and data audit trails.

* Responsible for conducting data integrity assessments of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements and company established requirements for data integrity.

* Responsible for conducting data integrity periodic reviews and performing risk monitoring of implemented systems to ensure continued compliance.

* Responsible for leading investigations and implementing corrective/preventative actions associated with data integrity events.

* Executes data integrity processes for automated systems in conjunction with computerized system development life cycle (SDLC) methodologies to ensure computerized systems meet regulatory requirements, company requirements and align with industry standards.

* Responsible for the authorship and review of effective Standard Operating Procedures associated with data integrity compliance.

* Responsible for conducting training on data integrity and associated processes.

* Seeks out and recommends to management opportunities for increased data integrity program efficiencies and operational improvement through modifications to current systems, implementation of new systems and more efficient use of established systems.

REQUIREMENTS

* 4-year college degree in Computer Science, Computer Engineering, Mathematics or in a science-related field.

* 3-5 years of work experience in manufacturing operations within the Pharmaceutical/Medical Device industry.

* Work experience in GxP regulations and Good Automated Manufacturing Practices (GAMP) principles with an emphasis in 21 CFR Part 11, 210, 211, 58 and 820.

* Work experience in managing multiple projects of varying degrees of complexity

Advanced Resources is a talent solutions organization headquartered in Chicago providing staffing, consulting, and workforce solutions nationwide. Our goal is to help people move their careers forward and help businesses solve their most complex challenges. Thanks to our commitment to providing an exceptional experience for both our clients and talent, we are a perennial winner of the prestigious Best of Staffing(R) Diamond Award. By placing our team, clients, and talent first, every day we make a difference.

It is Advanced Resources practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Advanced Resources is part of the Advanced Group, a talent acquisition and management, consulting, outsourcing, and professional services organization.


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