Twin Cities Quality Assurance Association

Quality Assurance Manager @ BIOLYPH

  • 05 Sep 2018 8:47 AM
    Message # 6654557

    BIOLYPH is seeking a Quality Assurance Manager to join our team and help us continue our tradition of exceeding Client expectations.

    About BIOLYPH 

    BIOLYPH, established in 1993, is a Biotechnology Manufacturing Service Company specializing in lyophilization located in Chaska, Minnesota.  Our customers are manufacturers of Diagnostic and Life Science Research Products.

    BIOLYPH believes our employees are a valuable asset.  We offer professional development to expand your skill set and enhance your career.  You will be working in a family-friendly environment with a great team of co-workers and managers.  At BIOLYPH, your work will impact lives including your own!

    A day in the life of the Quality Assurance Manager:

    • Quality and Compliance
      • Ensure BIOLYPH's established QS processes are followed with objective evidence of compliance
      • Facilitate Client and Prospect Quality audits
      • Conduct Internal Quality audit
      • Investigate deviations
      • Initiate NCS and CAPA activities
      • Complete SCARs
      • Complete Client Quality Surveys
      • Lead Management Review process and track team deliverables
      • Champion BIOLYPH's goal of Perfect Finished Parts
    • Systems and Procedures
      • Draft, manage the execution of, and review (as appropriate) equipment and process validations
      • Develop WI/SOPs as needed for business use
      • Create systems as needed when gaps are identified
    • Additional Responsibilities
      • Learn production processes, flow, and how to create built-in quality checks
      • Continuous Improvement activities
      • Assist with Employee Performance Assessments
      • Support of Production Team as needed

    What you need to be qualified for this job:

    • Bachelor's Degree in life science or similar field; related certifications
    • Quality Assurance/Regulatory Affairs experience in an FDA regulated manufacturing or other technical environment
    • GMP, GLP
    • 5+ years in Quality Assurance
    • ISO 13485 experience preferred
    • Experience with Quality Management System Software preferred

    Characteristics:

    • Excellent written and oral communication skills
    • High level of attention to detail
    • Proven experience in dealing with technical issues
    • Successful interaction with senior level management
    • Ability to work in fast paced environment
    • Makes decisions keeping "do the right thing" in mind

     BIOLYPH Offers:

    • Competitive pay
    • Company sponsored events
    • Clean, friendly, and comfortable work environment
    • Benefits for full-time employees include:
      • Health, Dental, Life and Short-term disability insurance
      • Paid Time Off, Paid Holidays, & Floating Holidays
      • 401k

    Are you ready to join our team?

    If you feel like you are the right candidate for this job, please email a cover letter, resume, and salary requirements to careers@biolyph.com or go to https://biolyph.applicantpro.com/jobs/859233-303916.html



© Twin Cities Quality Assurance Association (TCQAA) a 501c(3) organization. All Rights Reserved.

Powered by Wild Apricot Membership Software