Quality Control Associate I, Reagents

About the role

The Quality Control Associate I, Reagents will be responsible for executing core Quality Control (QC) processes associated with reagent consumable and bioassay production, reagent stability program, and controlled storage monitoring, assisting with incoming quality control, departmental calibration and maintenance and the retention program and maintaining QC laboratory supplies, preparing internal use laboratory reagents, as well as maintaining the integrity and cleanliness of QC work and storage areas. This position will be participating in QC processes associated with test method development, product development, and equipment/ method validations and have frequent intra-department interaction as well as frequent inter-department interfaces with Quality Assurance, Reagent Manufacturing, Design Transfer and Process Engineering, Production Planning, Purchasing, and Document Control.

Responsibilities

• Deliver timely and accurate Quality Control testing for bioassay and core consumable products.
• Deliver timely and accurate completion of quality control and manufacturing process documentation including related business system transactions.
• Generate Certificates of Quality
• Document and complete non-conformances
• Respond appropriately to environmental monitoring notifications of specialized storage areas; includes 24/7 call list rotation
• Execute stability study sample scheduling and processing.
• Participate in program to sustain orderliness and cleanliness within related quality control and manufacturing area through routing sorting, labeling, systematic cleaning, and standardizing.
• Assist in timely processing of purchased materials for release including related business system transactions.
• Assist in on-time maintenance and calibration of Reagent QC measuring and monitoring devices
• Schedule timely outsource testing and services with associated documentation of results.
• Assist in monitoring of departmental supplies and stocking of focused Reagent QC supplies; generate Purchase orders as needed.
• Assist in filing retentions and retention maintenance program.
• Prepare laboratory reagents for internal use
• Deliver timely and accurate completion of inventory cycle counts for select sub-inventories.
• Participate in applicable departmental and interdepartmental training
• Maintain current training to standard operating procedures, quality control instructions (QCIs), and applicable changes affecting quality control.
• May assist in training of QC Technician and QC Associates to task-specific operations.
• Assist in investigation and resolution of findings impacting Reagent Quality Control initiated through audits, non-conformances, correct