Quality Control Associate I, Reagents

5 months ago

Toronto, Canada DiaSorin Full time

**Job Title**: Quality Control Associate I, Reagents - Toronto

JOB SUMMARY
- 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.

Key Responsibilities and Duties
- 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

QUALIFICATIONS

Education

Bachelor's Degree B.S. in Chemistry, Biochemistry, Biology, or related science

Work Experience

1+ Years relevant experience in a Life Sciences, Chemistry, or Medical Technology related industry preferably in an FDA regulated and/or ISO certified operation

Physical Demands

Standing - Occasionally

Stooping - Occasionally

Bending - Occasionally

Climbing - Occasionally

Sitting - Occasionally

Kneeling - Occasionally

Lifting of at least 40lbs - Occasionally

Travel Requirements

No travel required

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