Quality Control Associate I, Reagents

5 months ago

Toronto, Canada DiaSorin Full time

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."

Why Join Diasorin?

**Impactful Work**: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

**Global Reach & Innovation**: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

**Diverse and Inclusive Culture**: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

**Join Our Team**: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Our Mission

We envision a Luminex solution in every lab around the world seeking to obtain timely and confident answers.

Our Vision

We aim to lead with transformative solutions that uniquely accelerate reliable answers while reducing the overall cost of advancing health.

A Brief Overview
- 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.

What you will do

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

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