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Randstad Quality Management Systems Technician in Big Flats, New York

Quality Management Systems Technician

job details:

  • location:Big Flats, NY

  • salary:$15.72 - $24.93 per hour

  • date posted:Wednesday, January 13, 2021

  • job type:Contract

  • industry:Information

  • reference:815448

job description

Quality Management Systems Technician

job summary:

A Quality Management Systems Technician is needed for a manufacturing company considered one of the world's leading innovators in materials science in the Big Flats, NY area. This job is responsible for day-to-day activities related to Quality Management System database entry and tracking. Responsible for quality system projects, audit readiness activities, improvements or initiatives. Responsible for creating and updating documents in a standardized format to clearly communicate complex and technical information to end users. Responsible for managing quality documentation while ensuring accuracy, quality and integrity.

location: Big Flats, New York

job type: Contract

salary: $15.72 - 24.93 per hour

work hours: 8am to 5pm

education: Associates


  • Extract technical information from subject matter expert(s) and clearly document the information in procedure format

  • Create and submit quality department change controls

  • Review and update information in the electronic document management system

  • Provide quality system database (e.g. EtQ, SharePoint, Box) day-to-day and test script support

  • Track, review, process, scan and securely file quality system paper-based and electronic documentation (change controls, CAPAs, experiments, reports, RCIs, SCARs, validations)

  • Review documents for accuracy and good documentation practices (GDP)

  • Maintain department metrics for use in identifying continuous improvement initiatives

  • Assign unique identification numbers to applicable documentation

  • Document action items and attendance during Change Review Board, CAPA Review Board and RCI meetings

  • Track CAPA and Change Control action items to closure

  • Participate in audits (internal and external) and support follow-up activities

  • Provide change control and training compliance back-up support as needed

  • Support validation activities as needed

  • Perform additional duties as assigned by supervisor

Preferred Education:

  • Minimum 2-year Associates degree

Required Years of Experience:

  • 1+ years of experience in a quality system, technical writing and/or information technology-related role; experience with cGMP industry standards and compliance is desired

Required Skills:

  • Able to handle complex tasks, work independently with strong time management and prioritization skills to handle multiple assignments and interact with cross-functional project teams.

  • Understanding of quality principles, practices and procedures to meet cGMP compliance

  • Intermediate to advanced knowledge of Microsoft Office (Word, Excel, Outlook) and software applications

  • Working knowledge of databases

  • Able to read, understand and adhere to documented procedures

  • Must be detail oriented and accurate with data entry

  • Ability to disambiguate

Desired Experience /Qualifications /Skills:

  • Experience working in an ISO and/or regulated industry environment

  • Change control, CAPA, compliance system experience

  • Experience working in pharmaceutical, medical device or automotive industries

Soft Skills:

  • strong written and verbal communication skills

  • Attention to detail

  • Organized with good planning and time management skills

  • Ability to build relationships within cross functional groups; team building skills

  • Positive attitude, flexible and good work ethic

  • Results oriented and high commitment



  • Experience level: Experienced

  • Minimum 1 year of experience

  • Education: Associates


  • Quality

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.