Quality Assurance Specialist

5 days ago


Raleigh, United States Technical Source Full time

Technical Source is currently in search of a Quality Specialist for our client located in the Raleigh-Durham, NC area. The qualified candidate will have experience investigating and resolving quality issues, ensuring ensures that products, services, and processes meet industry standards and customer expectations. Their role involves minimizing defects, maintaining regulatory compliance, and promoting continuous improvement. compliance with regulatory standards, and driving continuous process improvements in their designated area.


Responsibilities of the Quality Specialist include:

  • Investigate and resolve quality problems, including non-conformities and unscheduled events.
  • Ensure accuracy and timely approval of batch production records (BPR).
  • Collaborate with process teams to implement preventive actions for recurring quality issues.
  • Ensure compliance with training programs and assist in process confirmations to improve quality and compliance.


Qualifications of the Quality Specialist include:

  • 1-5+ years of Quality Assurance experience in a pharmaceutical environment. Experience in problem-solving and managing multiple tasks with proper prioritization.
  • Knowledge of US and EU regulations, GMPs, and quality standards. Ability to coach, develop, and motivate team members while promoting a collaborative and inclusive work environment.
  • Familiarity with Lean/Six Sigma methodologies and process improvement techniques is a strong plus.
  • Strong written communication, investigative writing, and computer skills (MS Office, SAP, LIMS).



Key Words: Quality Assurance (QA), Continuous Improvement, Compliance, Process Improvement, Root Cause Analysis (RCA, Regulatory Standards, Auditing, Quality Management Systems (QMS), GMP (Good Manufacturing Practices), Documentation, Reporting, Lean/Six Sigma



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