Quality Control Associate III, 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

This job will be executing Quality Control (QC) processes associated with production, purchased product, reagent stability program, retention program, controlled storage monitoring, and departmental calibration and maintenance including task-specific training and mentoring of other Reagent QC personnel. This job is responsible for assisting in creating or updating QC instructions or SOPs and perform the associated engineering change control, maintaining QC laboratory supplies/internal reagents as well as maintaining the integrity and cleanliness of QC work areas and participating and may lead in QC processes to support new product design transfer, process development, process validations, equipment validations, and the investigation and resolutions of product/process issues.

This job will 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 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.
• Prepare and verify Reagent Certificates of Quality
• Document non-conformances and participate in Material Review Board as required.
• Respond appropriately to environmental monitoring notifications of specialized storage areas; includes 24/7 call list rotation
• Assist in the planning, sample scheduling, and sample processing of product stability studies
• Assist in the cleanliness and integrity of QC laboratory and storage areas.
• 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 the maintenance of sectional retention program
• Oversee and assist in the scheduling and preparation of laboratory reagents for internal use
• Participate in or conduct applicable departmental and interdepartmental training; maintain current training to standard operating procedures per matrix, QCIs and applicable changes affecting reagent quality control
• Perform training of QC Technician, QC Associate, and Associate II personnel to task-specific operations, operating procedures, and standard operating procedures.
• Lead or assist in the investigation, resolution, and reporting of findings impacting Reagent QC initiated through audits, non-conformances, corrective/preventive actions, or customer complaints
• Deliver basic equipment validations plans and reports
• Lead and assist in creation and revision of standard operating procedures (SOPs), test methods, manufacturing instructions and deviations.
• Assist with quality control integration of new products and processes in collaboration with Design Transfer and Process Engineering team.
• Support design transfer with process improvement projects.
• Lead or assist in compilation and analysis of technical deliverables
• Participate in infrastructure improvement projects 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
• Perform QC Associate 1 responsibilities as required
• Log-in incoming samples for testing.
• Verify Reagent Quality Control and/or Manufacturing documentation
• Execute and assist in departmental document change control and engineering change control activities
• Assist in continuous improvement projects
• Lead or assist in planning and executing projects targeting efficiency, cost reduction, and quality improvements.
• Collect/compile data to monitor and report for out of control trends based on statistical process control limits and established performance criteria.
• Other duties as assigned.

Education, Experience and Qualifications

• Bachelor's Degree B.S. in Chemistry, Biochemistry, Biology, or related science disciplineOther duties as assigned.
• 3+ Years At least 3 years of relevant experience in a Life Sciences, Chemistry, or Medical Technology related industry preferably in an FDA regulated and/or ISO certified operation

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.