• Quality Assurance Manager

    Job Locations US-MN-St. Paul
    Posted Date 1 week ago(11/1/2019 4:13 PM)
    Job ID
    2019-1139
    # of Openings
    1
    Category
    Other
  • Overview

    The Quality Assurance Manager serves as the Quality Assurance Leader for the Corebiome business, including serving as designated management representative in charge of the correct execution of the QMS.

     

    The Quality Assurance Manager ensures CoreBiome services meet customer and regulatory requirements and are right the first time. In addition, they are responsible for maintaining the compliance of our Quality Management System (QMS) to applicable requirements including CLIA/CAP.

     

    The Quality Assurance Manager works closely with cross-functional teams to ensure our suppliers, procedures, and services consistently meet specified requirements.

    Qualifications

    EDUCATION:

     

    • Bachelors degree concentration in a scientific, engineering, or related area is preferred. Advanced degree (MBA, MS, or PhD) preferred. A combination of relevant job experience, training and knowledge will be considered.

     

    EXPERIENCE:

     

    • Minimum five years experience in a laboratory or GMP manufacturing setting.
    • Minimum one year experience in a Quality Assurance Leadership role, preferably in a regulated laboratory environment.
    • Excellent analytical and problem-solving skills, including previous experience with Statistical Process Control, Design of Experiments, and root cause analysis (preferred).
    • Experience with Pharmaceutical clinical trials desired.
    • Experience with Quality and Regulatory oversight, including ISO 13485:2016, ISO 9001:2015, FDA Good Manufacturing Practices (or QSR), ISO17025, ISO15189 a plus. 
    • Experience with obtaining and maintaining CLIA licenses for states of NY, PA, CA, MD, RI, FL preferred.
    • Experience managing relations with academic institutions, data transfer agreements, contracts, Quality Agreements, sponsor and vendor management desired.
    • Demonstrated resourcefulness with an ability to work with a diverse set of tasks and responsibilities.
    • Proven leadership and developmental abilities.
    • Strong time management, organizational and communication (written and oral) skills
    • Ability to conduct formal presentations in group settings and convey technical information.
    • Basic computer skills and proficient in MS Office 2010: Word, Excel, Power Point, and Outlook.

     

    Responsibilities

    • Ensures organization is in compliance with CLIA and CAP regulations.
    • Manages internal audit program and works with process owners to improve & ensure compliance of their procedures.
    • Manages corrective and preventative action (CAPA) process and lead continuous improvement activities.
    • Manages and provides oversight of the document control process.
    • Leads and supports periodic management reviews.
    • Partners with cross-functional team to audit suppliers, qualify new suppliers, and monitor performance of current suppliers, including supplier corrective action reports.
    • Works with departments to develop and monitor key performance indicators to assess performance of the organization and guide improvement efforts.
    • Investigates customer complaints.
    • Manages external customer audits.
    • Participates in new product introductions, customizations and service change processes to drive quality.
    • Reviews verification and validation plans and reports.
    • Manages and provides training to employees on aspects of the QMS that are relevant to their role.

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