and FDA inspections. Assess and Monitor Data Integrity Controls Verify systems meet FDA data integrity expectations (ALCOA.../PQ, traceability). Understanding of FDA data integrity principles (ALCOA+). Knowledge of risk-based validation...
to specify and/or purchase ALCOA ® Wheels. Additionally, this position requires extensive knowledge and thorough understanding... specification selling along with diligent follow-up after the fleet has converted to ALCOA® Wheels. Because of potential liability...
, and equipment qualification. Knowledge of FDA regulations, cGMP, GAMP 5, 21 CFR Part 11, ALCOA+, and validation lifecycle...
, biotechnology, or regulated manufacturing environments 5 years of experience in Data Integrity/ALCOA principles 5 years...
and ALCOA+ principles. - Deviation Identification and Investigation: Identify and escalate any atypical results and potential...
and participates in assigned qualification and validation activities, as necessary. The associate adheres to the ALCOA+ principles...
Verify systems meet FDA data integrity expectations (ALCOA+), including audit trails, access controls, and record retention... principles (ALCOA+). Knowledge of risk-based validation approaches (e.g., GAMP 5). Understanding of IT change management...
, etc.) with minimal supervision. Prepare and manage samples, reagents, standards, and controls following ALCOA+ principles. Maintain...
Glassware washing Use ALCOA to document test results in electronic notebooks Would support various QC labs where work...
regulatory documentation and TMFs in accordance with ALCOA principles. Monitor site inventory of investigational products...