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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, 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 validation and 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.
Job Responsibility:
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
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
Requirements:
Bachelor's Degree B.S. in Chemistry, Biochemistry, Biology, or related science discipline required
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
What we offer:
Receive a competitive salary and benefits package as you grow your career at DiaSorin