BIOLYPH, LLC
  • Chaska, MN, USA
  • Salary
  • Full Time

Competitive pay, Health, dental and short-term disability insurance, Paid holidays, Paid time off (PTO), 401k


Job Title: Quality Assurance Manager

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

BIOLYPH, LLC is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status

BIOLYPH, LLC
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