Quality Associate I - Cypress, United States - USA 2023-012

Job Title

Quality Associate I

Job Facts

Organizational Area
USA and Canada
Country / State
United States
Place of work
Cypress
Home/Office based
Office based

Professional Family: 

  • Quality
Reporting To
Manager

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
USA 2023-012

Job Scope

Your Mission

For over 40 years, DiaSorin has been on a mission on five continents to develop, produce and commercialize diagnostic tests for a wide range of clinical areas. Our tests are designed for hospitals and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics.

We believe in a respectful and supportive workplace that attracts and celebrates the uniqueness of a diverse workforce that represents our community and customers.

Main Responsibilities

Your Contributions

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.

Qualifications Experience Personal Strengths Mobility

You
Education
Bachelor’s Degree
Specialization
Biology
Experience

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

Technical Competencies

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.
Generate inspection data upon request for raw material releases for TAT determinations.
Perform label reconciliations from DHR 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.

Skills

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 DHR archiving, filing, and scanning.
Perform assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies.

Languages
English
Travel Availability
NA
Relocation Availability
NA
Training Required

YES

Benefits

We Offer You

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.

Others Information as per Local Legal Requirements

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

This contractor and subcontractor shall abide by the requirements of 41 CFR 60-1.4(a), 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

DiaSorin Inc and DiaSorin Molecular LLC are Affirmative Action and Equal Opportunity Employers. 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.

Equal Employment Opportunity

Posters: https://www.dol.gov/agencies/ofccp/posters.
If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email: hrtalent@diasorin.com. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail: hrtalent@diasorin.com or call toll-free 1.800.328.1482.