CAPS Qual Complnc Dta Stwrd II

$95,615 - $119,511/Yr

Central Admixture Pharmacy Services - Phoenix, AZ

Full-time - Mid Level

Phoenix, AZ

10,001+ employees

Health and Personal Care Retailers

About the position

The CAPS Qual Complnc Dta Stwrd II position at Central Admixture Pharmacy Services, Inc. is responsible for implementing and continuously improving the Site Data Integrity Program. This role requires maintaining knowledge of data integrity quality and regulatory requirements, identifying compliance risks, and developing solutions to address these gaps. The position involves coordinating the quality and security of laboratory and production data, ensuring compliance, and creating methodologies for tracking performance related to data integrity expectations.

Responsibilities

• Implement and continuously improve the Site Data Integrity Program.
• Maintain comprehensive knowledge of applicable data integrity quality and regulatory requirements, including 21 CFR Part 11.
• Identify data integrity compliance risks and gaps across the site and communicate those risks to Site Management.
• Develop and implement effective solutions to address identified gaps.
• Coordinate the quality, security, and maintenance of laboratory and production data to ensure compliance.
• Create data process mapping and risk reduction efforts for data owners and Quality representatives.
• Define data elements and establish policies and procedures related to data collection and accuracy.
• Perform tests and audits on data systems to ensure data quality is maintained.
• Provide expertise in data management and moderately complex project aspects.
• Create methodologies and metrics for tracking performance to required Data Integrity expectations.

Requirements

• Bachelor's degree required.
• 4-6 years of related experience required.
• Valid driver's license and passport required.
• Occasional business travel required.

Benefits

• Health insurance
• 401(k)
• Tuition reimbursement