Quality Assurance Data Integrity Reviewer

Founded in 1932, Xttrium Laboratories, Inc. is a Family Owned and Operated Company based out of the Chicagoland area. We are committed to human health and take great pride in being a leading manufacturer and supplier of antiseptic products across the country. Xttrium Laboratories began as a small group of doctors and nurses working to treat individual patient needs. Today, our portfolio has expanded to over 150 different FDA-approved infection prevention and healthcare products. With 85 years of experience, the Xttrium Team is driven to provide solutions to a wide variety of health and safety concerns.

Overall Responsibility

Responsible for performing review of all laboratory data with emphasis on Data Integrity and adherence to ALCOA principles to ensure adherence to regulatory standards including and not limited to Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

The reviewer verifies calculations, raw data at point of first capture, audits lab notebooks, and works with lab analysts to resolve discrepancies and enforces proper documentation practices.

Key areas of responsibility

• Review test data generated with laboratory instruments.
• Focus on detail for identifying inconsistencies and errors.
• Review instrument logbooks.
• Verify Standards and Reagents for expiry requirements.
• Ensure that all data generated in the lab is accounted for and justified.

Do you have experience in Laboratory instruments?, Do you have a Bachelor’s degree?, * Education: A Bachelor’s degree in a scientific field, for example Chemistry, Biology or Biochemistry.

• Technical Knowledge: Strong understanding of laboratory procedures, analytical instrumentation (e.g. HPLC, GC, FTIR, pH) and data integrity principles like ALCOA+++.

Prerequisites for the Job

• Previous experience in a regulated laboratory environment.
• Excellent verbal and written communication skills for providing clear feedback to lab personnel and documenting findings.
• Experience with data management software, Laboratory Information management systems and chromatography software.