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Quality Assurance Technician III

Company: Ascent
Location: Tucson
Posted on: November 10, 2019

Job Description:

19-08996/Quality Assurance Technician IIILocation: Tuscon, AZIndustry: Biotechnology / PharmaPosition Type: Initial 12?Month contract?Summary of job:The Quality Assurance Technician III is responsible for supporting various and a wide variety of activities within manufacturing and the QA team to ensure compliance with applicable regulatory and ISO requirements. The Quality Assurance Technician III will compile and review metrics and make recommendations for improvements to existing processes. This position will play a lead role in the MRB process.?Such activities consist of but are not limited to; ensuring product meets established specifications and requirements, procedures are followed, records are accurate as well as appropriate, the Quality System is monitored and issues elevated when necessary. This position also requires decisions be made to determine appropriate actions are taken throughout processes as defined by our procedures.?Job Duties:

  • Create and monitor Non-Conforming Reports (NCRs) as required.
  • Responsible to control and monitor quarantined and non-conforming materials.
  • Understand the requirements of the Quality System such as; Good Documentation Practices, Quality Systems Procedures, Work Instructions, Quality Records, Verification activities, Audits, training, Design Transfers, Validations, Non-Conforming Product, CAPA, Production/Process Controls, ESD, Handling, and Document/Data Control.
  • Compile, monitor and report Quality Assurance monthly metrics including identifying and/or preparing action plans for improvements.
  • Compile and maintain Quality Assurance daily metrics reporting any significant impact or opportunity to Quality Assurance and Quality Engineer managers.
  • Provide feedback to team members, operations and the Quality Assurance manager as appropriate.
  • Responsible for routinely conducting departmental Quality and/or Safety Audits.
  • Review, evaluate and disposition Quality Data; Review and evaluate quality records and Device History Records (DHRs) to ensure accuracy, completeness, appropriate release and control of product(s).
  • Monitor Production Processes as required.
  • Continuously promote ?Right First Time.?
  • Lead/participate in investigations (relating to problems, potential problems, failures and/or complaint data)
  • Ensure compliance with quality system requirements as it applies to the output of the defined job specifications.
  • Coordinate manufacturing and development projects (including Design transfers) as required.
  • Participate in daily production meetings as required.
  • Participate in continuous improvement initiatives.
  • Align with Quality Assurance team members that best balance with Quality, Operation, and Corporate
  • objectives.
  • Work with Engineers and subject matter experts to find root cause, participate in risk assessments, and create Change Orders.?Qualification/Education:
    • Associate?s Degree in related field.
    • CQA, CQT or equally recognized formal certifications in the field of Quality preferred.?Preferred Skills/Experience:
      • 4 years of experience working in the area of Quality.
      • Preferably 2 years experience in an FDA and/or ISO regulated industry.
      • Ability to conduct detailed acceptance and verification activities.
      • Ability to perform ERP transactions using PC based applications (prefer).
      • Working knowledge of computer applications (i.e.; word, excel, Microsoft, Power Point & SAP).
      • Proficient in basic math and English; including verbal/written skills and be able to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
      • Working knowledge of Reagent and/or Instrument manufacturing (use densities, tare weights, calculations to verify, interpret drawings, read gauges, knowledge of torques, etc.).
      • Ability to write reports, maintain data records, present information effectively and have strong communication skills with internal and/or external customers.???*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role*????

        Company Description:

        About Ascent:Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent---s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.If you are ready to propel your career to new heights--- read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

Keywords: Ascent, Tucson , Quality Assurance Technician III, Professions , Tucson, Arizona

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