Lead Reagent Quality Control Associate

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.

Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

Job Scope:

• Leading and participating in QC processes to support new product design transfer, process development, process validations, equipment validations and the investigation and resolution of product/process issues.
• Creating or updating QC instructions or SOPs and perform the associated engineering change control.
• Being a Rees administrator, ensuring compliance, issuing reports, and implementing changes in the Rees environmental monitoring system.
• Task-specific training and mentoring of other Reagent QC personnel.
• Executing Quality Control (QC) processes associated with production.
• Assisting in core functions involving purchased product, reagent stability program, retention program, and departmental calibration and maintenance.
• Frequent intra-department interaction as well as frequent inter-department interfaces with Quality Assurance, Reagent Manufacturing, Design Transfer, Purchasing, Document Control, and Research and Development.
• Being able to multi-task, meet deadlines, maintain flexibility, and work as a team member.

Key Duties and Responsibilities: 

• Deliver timely and accurate Quality Control testing for Reagent Bioassay and core Consumable standard inventory and build-to-order products.
• Deliver timely and accurate completion of quality control and manufacturing process documentation including related business system transactions.
• Deliver QC specific work order scheduling to achieve attainment of production and project due dates and optimal utilization of resources.
• Assist in developing and implementing daily work schedule, priorities, and task delegation within QC.
• Responsible for stability study sample planning, scheduling, and processing.
• Lead and participate in program to sustain orderliness and cleanliness within related quality control and manufacturing areas through routine sorting, labeling, systematic cleaning, and standardizing.
• Lead and assist in monitoring of departmental supplies and equipment required for testing; generate Purchase Orders as needed.
• Responsible for the scheduling of outsource testing and services
• Responsible for the scheduling and preparation of laboratory reagents for internal use
• Verify Reagent Quality Control or Manufacturing documentation.
• Prepare and verify Reagent Certificates of Quality.
• Issue Reagent Certificates of Quality.
• Document and complete non-conformances.
• Participate in Material Review Board as required.
• Conduct quality control record Completeness Reviews
• Participate in or conduct applicable departmental and interdepartmental training
• Maintain current training to standard operating procedures, quality control instructions (QCIs), and applicable changes affecting Reagent Quality Control.
• Deliver timely and accurate completion of inventory cycle counts for select sub-inventories.
• Perform Associate II, I or Technician responsibilities as required
• Perform training of QC Technician, QC Associate, Associate II, and Senior Associate personnel to task-specific operations, operating procedures, and standard operating procedures.
• Respond appropriately to environmental monitoring notifications of specialized storage areas.
• Act as Rees Environmental Monitoring System Administrator; monitor system, issue reports and monitor trends, implement changes within system, respond to departmental requests and provide setup and training. Correspond with Rees Scientific and other departments as necessary.
• Collect/compile data to monitor, report, and take action for out of control trends based on statistical process control limits and established performance criteria.
• Responsible for the compilation and analysis of technical deliverables.
• Plan and execute projects; compile, report, and present data and project conclusions.
• Assist with quality control integration of new product and process in collaboration with Design Transfer and Process Engineering team.
• Support design transfer with process improvement projects.
• Revise QCIs, manufacturing instructions, and standard operating procedures as required.
• Write basic equipment validations plans and reports
• Participate /execute equipment and process validations.
• Responsible for the creation and revision of standard operating procedures (SOPs), test methods, manufacturing instructions and deviations.
• Execute and assist in departmental document change control and engineering change control activities.
• Lead and assist in continuous improvement projects.
• Lead or participate in the effective prioritization, investigation, and resolution of findings impacting Reagent QC initiated through audits, non-conformances, corrective/preventive actions, or customer complaint escalation.
• Assist in planning and executing projects targeting efficiency, cost reduction, and quality improvements.
• Participate in infrastructure improvement projects affecting quality control.
• Assist in establishing annual CAPP objectives; fulfill individual CAPP objectives.
• Attend departmental planning and informational meetings as required representing Quality Control.
• Maintain personal compliance with Luminex Quality System including FDA, USDA, and ISO 13485:2012 requirements; 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.
• Interface with other departments as required.
• Other duties as assigned.

Education, Experience, and Qualifications:

• Bachelor's Degree in a Life Sciences, Chemistry, Medical Technology, or Biosciences field.

• Experience in quality control or manufacturing laboratory experience in a Life Sciences, Chemistry, Medical Technology, or Biotechnology field.
• Quality Control experience in a relevant ISO 13485; 2012 and or USDA/FDA regulated industry setting.
• Experience in immunoassay, proteomic and nucleic assay chemistry
• Relevant combinations of education, experience, training, and merit may be considered upon the review of Senior Director of Reagent Operations.

Training and Skills

• Thorough knowledge of ISO 13485:2012, FDA, and USDA Quality System requirements
• Thorough knowledge of immunoassay, proteomic and nucleic assay chemistry.
• Proficient in use of process based Manufacturing Resource Planning systems such as Oracle or SAP
• Proficient in the use of Product Lifecycle Management tools, including applied knowledge of Engineering Change Control.
• Proficient in Microsoft Word, Excel, and PowerPoint
• Proficient in written communication including document creation and revision and technical writing. Knowledge of Statistical Process control and application
• High mathematical and statistics aptitude including proficient data analysis skills
• Proficient oral communication
• Knowledge of Six Sigma and Lean Manufacturing processes desired
• Knowledge of statistical process control
• Knowledge in cleanroom operations and purified water systems
• Knowledge of industry standard practices for Biosafety Level 2 areas
• Ability to handle the pressure of meeting tight deadlines and adapting to rapidly changing priorities.
• Highly organized with proven time-management skills and prioritization skills
• Ability to work independently and with minimal supervision

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.

The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.