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.

    The Quality Assurance Manager will be responsible for ensuring that our products and services meet all the necessary requirements before they reach BIOLYPH’s Clients.  They will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures, and controls ensuring that the quality of our products and services conform to established requirements, standards, and agency regulations.

    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:

    Strategic planning and establishing policies and procedures at all levels to ensure BIOLYPH's QS processes are followed with objective evidence of compliance that meet or exceed BIOLYPH’s and our Clients’ needs and expectations.

    • Quality and Compliance
    • Facilitate Internal, Client, and Prospect Quality audits
    • 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
    • Assist with daily production quality questions / issues
    Systems and Procedures
    • Maintain the company's quality program that models the intent of ISO 13485 and cGMP (21CFR Part 820) through documentation, training, and implementation.
    • Ensures change/document control effectiveness of Quality Manual, SOPs, and Work Instructions as needed for business use
    • Draft, manage the execution of, and review (as appropriate) equipment and process validations
    • Create systems as needed when gaps are identified
    • Formulates and maintains quality objectives complementary to BIOLYPH’s policies and goals
    Additional Responsibilities
    • Learn production processes, flow, and how to create built-in quality check
    • Continuous Improvement activities
    • Assist with Employee Performance Assessments
    • Support the Production Team as needed
    • Establishes and maintains relations with customer quality representatives.

    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’ experience in a demonstrated Quality Leader role
    • ISO 13485 experience preferred
    • Experience with Quality Management System Software preferred

    Characteristics:

    • Advanced written and oral communication, interpersonal, negotiation, problem-solving, and time and priority skills
    • Ability to meet deadlines and maintain focus on quality deliverables
    • A proven track record of clearly demonstrated leadership and assertiveness skills
    • Thorough and observant with a high level of attention to detail
    • Ability to perform in a 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
    • Health, Dental, Vision, Life, and Short-term disability insurance
    • Paid Time Off, Paid Holidays including Floating Holidays, Paid Birthdays
    • 401k
    • Employee Assistance Program

    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


    Last modified: 19 Dec 2018 12:07 PM | Jamie Burk


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