Seeking a Quality Control / Quality Assurance Analyst to support laboratory quality operations through analytical data review, investigation support, and documentation of GxP quality processes within a regulated laboratory environment.
Job Responsibilities
Perform quality control and quality assurance activities supporting laboratory operations and compliance requirements.
Conduct routine and complex analytical data reviews, including reagent reviews, pH data review, visual data assessments, and instrument-generated data review.
Review analytical chemistry data from laboratory instrumentation, including chromatographic data (HPLC/GC), titrators, density meters, and FTIR analysis.
Support investigations related to Out of Specification (OOS) and Out of Trend (OOT) results.
Utilize electronic systems and quality tools to evaluate, document, and maintain records related to laboratory quality processes.
Partner with chemists and microbiologists to assess laboratory results and ensure accurate documentation.
Perform additional quality-related activities and support continuous improvement initiatives as needed.
Job Qualifications
Bachelor’s degree in a scientific discipline or equivalent laboratory experience preferred.
Minimum of 2 years of experience working in a GxP laboratory environment.
Experience supporting current Good Manufacturing Practice (cGMP) or other regulated GxP environments.
Hands-on experience performing analytical chemistry data review.
Experience reviewing laboratory data generated from analytical instrumentation.
Proficiency with Microsoft Office applications.
Strong written and verbal communication skills in English.
Experience using Laboratory Information Management Systems (LIMS) preferred.
Experience reviewing chromatography data using Empower, LabX, and/or Omnic software preferred.
Seniority level
Entry level
Employment type
Contract
Job function
Quality Assurance, Science, and Manufacturing
Industries
Medical Equipment Manufacturing
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