Associate I, Quality Assurance, Operations Materials

Responsibilities

• Perform day-to-day material release activities, including review of material documentation for completeness, accuracy, and other GDP requirements; generation of disposition labels; and the physical labeling of materials for appropriate disposition.
• Support migration of paper-based processes into the eQMS, including transition from Part Number Data Sheets to Material Specification and Release records.
• Digitize paper records, including material release files, logbooks, and other quality records, as needed to support electronic recordkeeping and records management activities.
• Maintain paper records archival, storage, inventory, and retrieval processes, including coordination of record box retrieval from the external records' archival vendor facility.
• Review controlled equipment, facility, and laboratory logbooks for adherence to Good Documentation Practices requirements and collaborate with department owners to address required corrections.
• Prepare metrics for monthly and quarterly review meetings, including material release activity, turnaround time (TAT), release failures, and related trends or process performance indicators.
• Support other QA department activities, as assigned by management.

Requirements

• Achieve intermediate knowledge of Microsoft applications, including Word, PowerPoint, and Excel.
• Achieve intermediate knowledge of Adobe Acrobat Pro.
• Ability to lift, pull, and move boxes weighing up to 30 pounds.
• Ability to perform job duties that require reaching, squatting, bending, pulling, kneeling, grasping, pinching, and finger/wrist dexterity.
• Sufficient visual acuity to proofread small print on labels and accurately distinguish colors.
• Ability to travel between Artiva’s Headquarters at 5505 Morehouse Drive and the Materials Management Warehouse at 5360 Eastgate Mall in San Diego, CA, as required to support job responsibilities.