Associate, Quality I

• 
  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.
  

Job Scope

Support the quality management system and regulatory requirements for DiaSorin Molecular LLC to comply with all applicable regulations and standards including but not limited to FDA, ISO, as well as Federal, State, and local agencies. Supports corporate goals and business growth.Provide general support to the operation of the Quality departments. Supports all applicable regulations including but not limited to FDA, ISO, IVDD, and IVDR requirements.

Key Duties and Responsibilities

• Inspect and verify product labels and inserts.
• Perform document and data review for material, intermediate, component, and kit releases.
• Review and approve device history records.
• Perform raw material inspection, labeling, and release.
• Review and approve raw material specifications for material release.
• Perform label reconciliations from Batch Records and label request forms.
• Complete release documentation such as release forms and status labels.
• Input and update release data into database systems.
• Conduct review for compliance to and complete documentation within GxP requirements such as GDPs and GMPs. Notify Production and Quality departments of document deficiencies and work with the departments to bring the documentation in compliance.
• Attend interdepartmental planning or scheduling meetings, such as KANBAN, MRB, etc. as necessary or appropriate, to support and coordinate product release and prevent product or material backorders.
• Maintain controlled procedures and forms related to final and intermediate product documentation review and release.
• Perform and maintain systems for process monitoring.
• Initiate document change requests to update documents as appropriate.
• Initiate non-conforming material reports to document material, component and product non-conformances as appropriate.
• Initiate deviation forms to document manufacturing process changes as appropriate.
• Initiate, and review Certificate of Analysis and Certificate of Conformance forms.
• Work with Manufacturing, and Quality departments to maintain accuracy and completeness of manufacturing, raw material, and quality control specifications.
• Assist with Batch Records archiving, filing, and scanning.
• Responsible for performing assigned tasks in accordance with the company's quality policies and procedures per the applicable quality management system regulations as defined in the Quality Manual.
• Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies. Violations of EHS regulations or policies will be handled in accordance with the established Company disciplinary process.
• Perform other duties as assigned.

Education Qualifications, Experience, and Qualifications

• Must have Associate's degree in life science or engineering technology or combination of equivalent work experience and education.
• Strong oral, written, communication, presentation, and interpersonal skills are required. Typically interfaces with multiple levels within organization.
• Must be PC literate with advanced Microsoft Word and Excel skills. Knowledge of GxP requirements such as GDPs and GMPs, is preferable.
• Ability to understand and apply sampling plans and techniques is also preferred.

Language Skills

• Ability to read, speak, write and understand the English language.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write reports and correspondence regarding quality issues.
• Ability to edit and proof documents with detailed accuracy.
• Ability to speak effectively before groups of customers or employees of organization.

Mathematical Skills

• Ability to add and subtract two digit numbers and to multiply and divide with 10's and 100's.
• Ability to perform these operations using units of American money and weight measurement, volume, and distance.

Reasoning Ability

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Physical Demands

• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel. The employee frequently is required to sit. The employee is occasionally required to stand, walk, reach with hands and arms, and talk or hear. The employee must regularly lift and/or move up to 30 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus

What we offer

Salary Range

The hourly rate for this position is $20.00 to $22.50 per hour. The hourly rate for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.