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Senior Quality Assurance Specialist

2 months ago


Fort Worth, Texas, United States Source One Technical Solutions Full time
Job Overview

Source One Technical Solutions is seeking a highly skilled Senior Quality Assurance Specialist to join our team as a consultant with a major medical device company in the pharmaceutical industry.

Key Responsibilities:

  • Perform instrument preventive maintenance, performance verification, and troubleshooting to ensure compliance with regulatory standards and company policies.
  • Write and review validation protocols, technical reports, and standard operating procedures (SOPs) to ensure accuracy and adherence to industry regulations.
  • Review and analyze internal and external documents to identify areas for improvement and make recommendations for process enhancements.
  • Collect, calculate, interpret, document, and report test results to ensure data integrity and compliance with ALCOA principles.
  • Develop and implement SOPs related to testing programs, laboratory operations, and equipment operation to ensure consistency and quality.
  • Investigate laboratory quality issues, recommend corrective actions, and lead laboratory investigations to resolve issues and improve processes.
  • Perform equipment calibration and maintenance, and serve as an instrument advocate to ensure optimal performance and compliance.
  • Identify and recommend laboratory instrumentation purchases, perform qualification and validation, and conduct peer review and approval of data collected by coworkers.
  • Lead laboratory initiatives and programs, train analysts on internal procedures and test methods, and perform statistical analysis to support decision-making.
  • Act as a subject matter expert (SME) for critical processes and testing, and support tracking and reporting laboratory performance metrics.

Requirements:

  • Perform instrument qualification, write qualification protocols, and execute qualification protocols for HPLC, HPIC, UPLC, and other laboratory equipment.
  • Write SOPs, conduct training, and resolve issues related to instrument troubleshooting and investigation.
  • Perform PM/PV on various equipment, including Osmometer, Viscometer, Turbidimeter, pH meter, Conductivity meter, Centrifuge, UV Spectrophotometer, Fluorescence Spectrophotometer, Rheometer, Karl Fischer, and particle size analyzer.
  • Write and review technical documents, manage projects, and demonstrate leadership skills.
  • The ability to fluently read, write, understand, and communicate in English.
  • 10 years of relevant experience and 2 years of demonstrated leadership experience.

About Source One Technical Solutions:

Source One Technical Solutions is a WBENC-certified woman-owned company providing a full range of professionals to the pharmaceutical, healthcare, defense, technology, financial services, retail, manufacturing, and energy and transportation industries nationwide.