Quality Assurance Specialist Position Available In Durham, North Carolina
Tallo's Job Summary: The Quality Assurance Specialist position in Morrisville, NC offers an hourly salary range of $35.00 to $40.00 USD, with a work arrangement of 4 onsite days and 1 remote day. Responsibilities include maintaining quality policies, ensuring regulatory compliance, and supporting software validation efforts. Minimum qualifications include a relevant bachelor's degree or 5 years of industry experience, with 2 years in Quality Assurance. Preferred qualifications include experience in pharmaceutical or biotechnology industries and familiarity with FDA requirements. For more information, contact ldeline@judge.com.
Job Description
Location:
Durham, NC Salary:
$35.00 USD Hourly – $40.00
USD Hourly Description:
Quality Assurance Specialist Location:
Morrisville, NC Work Arrangement:
4 days onsite, 1 day remote
Team:
Quality & Regulatory Affairs Job Type:
6+ month contract About the Job At Foundation Medicine, we’re committed to transforming cancer care through data-driven insights. As a Quality Assurance Specialist, you’ll play a key role in ensuring our operations meet the highest standards of regulatory compliance. You’ll support the development and maintenance of our quality systems, contribute to software validation efforts, and help ensure our work aligns with CLIA, CAP, and FDA requirements. Minimum Qualifications Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Quality Management) OR Minimum of 5 years of relevant industry experience in lieu of a degree At least 2 years of direct experience in Quality Assurance Preferred Qualifications Experience in the pharmaceutical, biotechnology, medical device, or diagnostics industries Familiarity with GLP, GCP, and FDA regulatory requirements Experience with clinical software validation and documentation (e.g., IQ, OQ, URS) Exposure to custom and COTS (commercial off-the-shelf) software validation Experience supporting external audits and vendor assessments Responsibilities Maintain and update quality policies, protocols, and controlled documents Ensure compliance with FDA/GLP record-keeping standards (ALCOA principles) Review and provide feedback on IT change control and software validation documentation Support the development and continuous improvement of the Quality Management System (QMS) Apply CAPA processes to address audit findings and quality issues Manage and maintain employee training records Collaborate with cross-functional teams to ensure quality standards are met across operations Skills & Competencies Strong attention to detail and organizational skills Excellent written and verbal communication Analytical mindset with strong problem-solving abilities Ability to work independently and meet deadlines in a fast-paced environment Proficiency in quality systems and documentation tools By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively “Judge”) to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge’s Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
ldeline@judge.com This job and many more are available through The Judge Group. Find us on the web at www.judge.com
