Data Integrity Officer at Day & Zimmermann in Saint Louis, MO
Responsibilities Ensure all new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage, and review of audit trails and regulations Communicate actions, compliance gaps, and commitments Perform risk assessments and data process mapping to determine high risk equipment and audit trails and take appropriate action to bring into compliance Assist in sourcing, assessing, and recommending instrumentation/equipment for purchase. Provide periodic training to site GMP personnel to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practices. Create/update procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations Routinely evaluate regulatory inspection documents and update site procedures accordingly Create and execute Change Controls for instrumentation/equipment Aid in establishing user requirements for equipment Qualifications Bachelor's degree in a scientific, engineering or related discipline Minimum of 7 years' experience in a regulated industry Ideal candidates will have solid technical knowledge of data integrity related to computer systems, data related to manufacturing equipment, and the like. Experience in data review (ex. TrackWise, etc) Solid knowledge of cGMP and cGDP
Salary Range:
$100K -- $150K
Minimum Qualification
Data Science & Machine Learning, Database AdministrationEstimated Salary: $20 to $28 per hour based on qualifications.
Salary Range:
$100K -- $150K
Minimum Qualification
Data Science & Machine Learning, Database AdministrationEstimated Salary: $20 to $28 per hour based on qualifications.
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