Quality Associate

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Quality Associate

September 2020

HemoSonics, LLC is seeking a Quality Associate who will be responsible for overseeing document control activities, training activities, and equipment calibrations. The Quality Associate is also responsible for assisting with the review of manufacturing records for accuracy and completeness to ensure compliance as well as timely release.

Key Attributes of the Successful Candidate:

  • Working knowledge of current and applicable GMP regulations e.g.: 21 CFR Part 820/ ISO 13485:2016.
  • Working knowledge of document control activities, training management, and cGMP / cGDP.
  • Working knowledge of Nonconformance/Deviation, CAPA and Change Control programs with experience in writing and reviewing of documentation for these processes.
  • Detail-oriented and excellent problem-solving skills.
  • Ability to positively interact with internal / external associates to quickly and effectively resolve documentation related issues.
  • Excellent verbal/written communication.
  • With minimal direction, ability to prioritize and manage multiple tasks simultaneously in a fast-paced environment.
  • Advanced computer skills (Excel, Power Point, MS Word, etc.).

Key Responsibilities:

  • Ensure the document control system is maintained and managed via cataloguing, circulating, sending out training update notices and maintaining documents.
  • Maintain secure control of all records for which the team is responsible, to include scanning into drive and filing.
  • Maintain the training tracking system, training files and training binders.
  • Maintain the calibration program for all facilities.
  • Maintain the document control system, ensuring timely release of new and newly revised documents, sending out training update notices, and filing of documents.
  • Collect and report metrics to drive the achievement of specific goals pertinent to the position.
  • Participate as a resource in process/product validations.
  • Assist with maintenance of the Device History files and other quality system documents.
  • Participate in internal audits and external agency inspections.
  • Assist with review of Nonconformance/Deviation, CAPA and Change Control systems to ensure timely documentation and closure.
  • Assist others, as needed, with information or reviews to support investigations.
  • Review batch records and other associated documentation to ensure compliance with SOPs, Work Instructions, and cGMPs.
  • Assist with disposition of finished product in accordance with SOPs and Work Instructions.
  • Assist with review of incoming inspection documentation.
  • Supports internal and external supplier audits and inspections.
  • Perform other Quality Systems/Quality Assurance duties as required to ensure compliance in the QMS.

Education and Experience Required:

  • Requires a Bachelor’s degree in technical field and 1-3 years of experience; or equivalent combination of education and experience.
  • Experience with laboratory or manufacturing quality assurance activities.
  • Experience working in IVD industry a plus.

The position is based in Durham, NC.

To apply, please email your cover letter, resume and salary requirements to: careers@hemosonics.com.

HemoSonics, LLC is an equal opportunity employer. All applicants will be considered for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Why HemoSonics?

HemoSonics is a growing team of scientists, engineers, regulatory and business professionals all focused on transforming the way clinicians manage coagulation dysfunctions by providing comprehensive, timely information on coagulation status at the point of care.

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