Quality Control Associate II, Reagents

DiaSorin•Austin, TX

32d

About The Position

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist." Job Scope: 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. Maintaining QC laboratory supplies, preparing internal use laboratory reagents, as well as maintaining the integrity and cleanliness of QC work and storage areas. Participating in QC processes associated with test method development, product development, and equipment/ method validations. 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.

Requirements

Bachelor's Degree B.S. in Chemistry, Biochemistry, Biology, or related science discipline
At least 1 year of relevant experience in a Life Sciences, Chemistry, or Medical Technology related industry preferably in an FDA regulated and/or ISO certified operation

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, corrective/preventive actions, or customer complaint escalation.
Assist in the execution of validations of test methods, equipment, and processes.
Assist in the review or revision of reagent QCIs, manufacturing instructions, and SOPs as required.
Support design transfer and the integration of new products and processes
Support process development and process improvement projects.
Assist in compilation of technical deliverables as required.
May participate in infrastructure improvements affecting quality control.
Maintain effective and professional multi-level organizational interfaces
Ensure personal compliance with Quality System; facilitate sectional compliance with the Quality System.
Adhere to safety, disposal and gowning requirements applicable to department; facilitate departmental safety compliance.
Participate in additional quality activities as required
Other duties as assigned.