Quality Assurance Specialist
The role of the Quality Assurance Specialist is to assess and assure study, project and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits. A Quality Assurance Specialist will coordinate auditing activities to ensure compliance with SOPs and GLP requirements; perform a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits, inspections, data and documentation reviews.
• Audits protocols, amendments, raw data, reports, and supporting documentation for internal accuracy, consistency, and conformance with regulations.
• Performs phase inspections of ongoing study activities.
• Prepares, issues, and tracks reports of observations noted during audits and inspections.
• Performs facility audits to ensure departmental compliance with the regulations.
• Provides risk-based compliance opinions and guidance.
• Identifies compliance gaps in processes, systems and studies; influences and collaborates with employees and management
• Assists with representing QA in internal work groups.
• Recognizes and supports opportunities for functional area improvement.
• May audit analytical portions of studies for consistency and compliance with the regulations.
• Reviews and updates Quality Assurance SOPs as assigned.
Knowledge, Skills and Abilities:
• Demonstrated knowledge of regulatory agency inspections, internal and external audits.
• Competency with computer applications such as MS Office and Outlook.
• High level of attention to details, accuracy and precision.
• Ability to work independently as well as in a team.
• Ability to Multitask.
• Ability to adapt quickly to changing priorities and projects.
• Excellent oral and written communication skills
• Bachelor's degree (B. S.) in a scientific discipline, or equivalent combination of education and experience.
• Two to three years related technical experience and/or training. A minimum of two years auditing in a GLP-regulated environment.
QA Compliant provides industry-leading audit, consulting, training, and advisory services to many of the world's leading pharmaceutical, biotech, agricultural, and life science companies. Clients count on QA Compliant to help them manage strategic operations by providing comprehensive customized solutions to our client's compliance, regulatory, and quality assurance needs. Through proven quality by design methodologies we effectively partner with our clients to minimize regulatory risk. QA Compliant specializes in FDA, EPA, OECD, ISO 9000, EU, and regulations with a focus of Good Laboratory Practices (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). www.QACompliant.com
QA Compliant offers a competitive compensation, great benefits, a flexible work schedule, and a casual working environment.
QA Compliant, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age.
Thu, 7 Sep 2017 10:25:57 PDT