• Quality System Specialist

    Job Locations US-MA-North Reading
    Posted Date 2 weeks ago(1/3/2019 3:10 PM)
    Job ID
  • ­


    The Regulatory and Quality Compliance team is responsible for ensuring that TraceLink products and services are complaint with relevant global regulations and standards for the life sciences industry, including but not limited to: 21 CFR Part 11, 21 CFR 820, 21 CFR 211, ISO 9001:2015, ISO 27001:2013, GdocP, GDPR, GAMP 5, and EU Guidelines (Annex 4 and Annex11).


    The Quality System Specialist will be responsible for TraceLink Quality Management System compliance, performing assessments of relevant or emerging global regulations for integration into the TraceLink Quality Management System, and implementing new processes or process improvements across the organization collaborating with other functions to holistically create a culture of quality and compliance. The Quality System Specialist will also assist with external audits, internal audits, records management, data integrity initiatives, risk management initiatives, and other duties as assigned.



    • Maintain, modify, and grow the TraceLink Quality Management System to comply with industry and federal regulations (21 CFR 11, GxP, and corporate strategic goals)
    • Manage revision and approval of the Quality System Policies, Procedures, Work Instructions, and Templates, including but not limited to: periodic reviews, change control, document management, records management, and good documentation practices
    • Monitor compliance to the Quality Management System and relevant global regulations for the company’s Development, Professional Services, Support, and IT organizations
    • Perform internal quality audits of the organization, including quality system inspection and reporting for areas documented in the internal audit plan and quality plan
    • Support hosting of customer audits and provide responses to customer audit reports
    • Perform Corrective Action and Preventative Action (CAPA) and Deviation management work, as assigned; and collaborate with department managers to address and manage CAPAs and Root Cause Analysis documentation to ensure customer satisfaction and process improvements
    • Stay abreast of relevant industry and federal regulations; and, provide guidance and expertise to the global organization in the areas of regulatory compliance and quality



    • Bachelor’s Degree, preferably in the Life Sciences, Engineering, Technical Communications, or an equivalent field of study or equivalent working experience required.
    • Minimum of 3 years’ experience in a quality management system, quality assurance, or regulatory affairs role.
    • Must have strong computer skills, i.e., word processing, flow chart, spreadsheets, data analysis, etc.
    • Must exhibit strong and effective communication skills.
    • Must have effective technical writing or procedure writing, process audit, or process improvement skills.
    • Must be able to maintain a high activity level and be able to effectively manage and prioritize
    • Experience in FDA regulated industry preferred
    • Lean/Six Sigma, data analysis/quality metrics reporting/statistics, or Process Improvement experience or certifications
    • ASQ (CQA, CQE, ISO Lead Auditor, or similar), or other accredited training or certifications


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