Quality Systems Associate - Stillwater, United States - USA 2022-075

Job Title

Quality Systems Associate

Job Facts

Organizational Area
USA and Canada
Country / State
United States
Place of work
Stillwater
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 2022-075

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

This position is responsible for overseeing, monitoring and enhancing the existing DiaSorin documentation system as well as performing final review and approval of device history records.

Qualifications Experience Personal Strengths Mobility

You
Education
Associate’s Degree in Quality, Technical Documentation, Data Analysis or equivalent experience.
Specialization
Quality, Technical Documentation, Data Analysis
Experience

• Manage documentation review and approval cycles through the SmartSolve Document Module
• Ensure good documentation practices are followed across various departments within DiaSorin Inc.
• Prepare and support rapid and deadline driven document delivery for Quality, Compliance and Regulatory inspections as assigned.
• Review and provide guidance on record completion and approve final manufacturing lot documentation.
• Review document change plans to assure compliance with QMS requirements.
• Review for format and prepare release versions of product labeling (IFU).
• Upload and confirm customer facing device labeling (IFU, MSDS) on web portal.

Technical Competencies

• Minimum of 1 year in related field or demonstrated documentation system competence within a cGMP corporate environment
• 1+ years of related documentation system experience within regulated environment.
• Good communication skills
• Service oriented mentality and a strong focus on customer needs
• Strong independent / cross-disciplinary skills
• Experience using Microsoft Office (MS Word, Excel, PowerPoint) and Google suite
• Ability to work independently with minimal supervision as well as with a team
• Ability to work in a regulated environment
• Ability to train team members on basic group procedures and tasks
• Effective process management and analytical skills
• Travel: Not typical
• Must be able to remain in a stationary position for at least 50% of the time.
• Constantly operates a computer requiring repeated motions of arms, wrists and hands.
• Occasionally moves in and around the workplace for purposes of accessing office equipment, meeting with others, etc.
• Occasionally lifts up to 15 pounds.
• Work is performed in an office and/or at home.

Skills

• Coordinate documentation translation.
• Create and maintain part information (bills of material, routings, etc.) in SAP.
• Provide training and guidance to the organization related to quality system documentation practices.
• Design and develop processes to implement and improve the QMS.
• Maintains and troubleshoots processes and procedures. Helps define QMS requirements

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.