Data Integrity & CSV Specialist (Onsite, Life Sciences)
ZP Group
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Job summary
ZP Group is seeking a Data Integrity / CSV Specialist for our Titusville, NJ site. This onsite role focuses on Data Integrity, CSV, risk assessments, and data process flow mapping to support quality and compliance initiatives through 2027.
The candidate will collaborate with site teams to assess systems, walk through laboratory environments, and drive remediation activities with strong Data Integrity expertise.
Qualifications
- Experience with Data Integrity and CSV in GMP environments.
- Knowledge of 21 CFR Part 11 and data integrity principles.
- EU GMP Annex 11 knowledge and practical application.
- Ability to perform data flow mapping, risk and gap assessments.
- Strong documentation practices and ALCOA+ adherence.
- Onsite collaboration with cross-functional teams.
- Excellent communication with QA, IT, and engineering.
Responsibilities
- Support Data Integrity assessments across lab, quality, IT, and site functions.
- Lead Data Process Flow Mapping initiatives.
- Perform Data Integrity gap and risk assessments for computerized systems.
- Conduct onsite reviews to identify data integrity risks and remediation opportunities.
- Provide CSV and Data Integrity guidance during system implementations.
- Assist audits and inspections as Data Integrity SME.
- Stay current with CSV and Data Integrity regulations and best practices.
Skills
Education
Tools
Job description
ZP Group is seeking a Data Integrity / CSV Specialist for our Titusville, NJ site. This onsite role focuses on Data Integrity, CSV, risk assessments, and data process flow mapping to support quality and compliance initiatives through 2027.
The candidate will collaborate with site teams to assess systems, walk through laboratory environments, and drive remediation activities with strong Data Integrity expertise.
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