Skip to main content

Quality Specialist

Primary Location: Durham, North Carolina, United States Full time R1343031 投稿日: 03/21/2023

Job description

The Lab Quality Specialist is responsible for supporting lab quality control processes and improvements.


  • Responsible for providing Quality Control (QC) documentation support to operations.
  • Performs QC review of lab documentation to ensure accuracy and compliance with applicable regulations and SOP's.
  • Supports the review and update of QC related SOP's.
  • Supports client audits by responding to routine inquiries and review of documentation ahead of audit to ensure readiness. Flags identified gaps to senior level staff.
  • Supports QC educational programs such as in-house workshops, presentations, training and seminars for new hires and existing staff. Assists in drafting materials and lab staff training delivery.
  • May work with management to update job training matrix.
  • Coordinates and schedules all assigned QC projects with minor assistance from coworkers and manager.
  • May track and report deviation QC trends to management.
  • Participates in QC and company staff meetings and discuss findings and recommendations for resolving non-compliance.
  • Evaluates QC processes for gaps, recommend actions and communicate to management the analysis to support the continuous improvement of lab quality.
  • Mentors and guides junior level staff. Supports the onboarding of new hires.
  • Participates in continuing education through self-study, attending training sessions and  lectures and meetings.
  • Supports safety, quality, and 6S requirements and initiatives.
  • Complies with company's procedures and regulatory requirements, as applicable.


  • Bachelor's Degree in medical technology or equivalent required.
  • 1 year of experience in a regulated laboratory environment.


  • Requires sound knowledge of laboratory quality systems and laboratory procedures.
  • Requires sound knowledge of laboratory good documentation practices.
  • Demonstrated ability to identify lab quality process gaps and propose basic resolution.
  • Good computer skills using Microsoft Outlook, Word and Excel.
  • Effective organizational and interpersonal skills.
  • Effective communication and presentation skills.
  • Capable of handling multiple tasks simultaneously.
  • Strong attention to detail and accuracy.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Applicable certifications and licenses as required by local regulations.

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status.


IQVIA Talent Networkに登録する


Talent Networkに参加する
Top of page