Quality Control Associate I, Reagents

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  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.
  

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  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.
  

Job Scope

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.

Key Duties and 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

Education, Experience, and Qualifications

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

1+ Years 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 required

Standard Physical Demands

Standing - Occasionally

Stooping - Occasionally

Bending - Occasionally

Climbing - Occasionally

Sitting - Occasionally

Kneeling - Occasionally

Lifting of at least 40lbs - Occasionally

What we offer

Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.