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Senior Quality Assurance Specialist
2 months ago
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.