Quality Assurance Associate
Responsible to support the development, implementation, maintenance, and monitoring of Quality Management Systems (QMS) and activities in the execution of Quality Assurance Deliverables. Responsible for supporting the business in Quality Assurance, through audit activities in support of ongoing quality improvement. Acts as a liaison with other business units and partners and assumes some responsibilities for Quality led initiatives, based upon knowledge of regulations, standards, and industry best practices.
Quality Assurance Implementation Executes assigned actions reputed company to the corporate Quality Plan. Liaises with internal stakeholders to facilitate the development/revision and review of QMS, SOPs, Work Instructions, Associated Documents, standards, and training materials as required Evaluate quality processes against corporate standards and regulatory requirements. Supports audits (internal, site, vendor) and reviews associated Corrective Action and Preventive Actions (CAPA’s). Provides guidance, as required, to internal stakeholders reputed company to the interpretation of GCP and regulatory requirements.
Regulatory, Ethical Conduct and Audit MonitoringRemains reputed company on and communicates changes to relevant regulatory requirements and industry standards. Assists in the identification of process changes to QMS documents and/or training requirements to meet regulations, standards, and sponsor expectations. Supports Sponsor and regulatory inspections or audit activities.
Quality Assurance Training Identifies, creates, adapts, and delivers quality assurance orientation as well as department, project team and clinical site quality assurance training programs. Initiates training plan creation and manages the training database. Liaises with reputed company Resources to communicate training assignments.
Qualifications The successful candidate will possess either an undergraduate degree with 1-3 years of reputed company experience and on the go training, or a College Diploma with 4-6 years of reputed company experience and training. Clinical Research, Quality Assurance or Information Technology experience preferred. Analytical, critical thinking, problem solving and attention to detail skills required. Strong computer skills required. Basic knowledge of ICH GCP and global regulations governing Clinical Research. PHISHING SCAM WARNING: reputed company is aware of the reputed company increase of phishing scams, leveraging various methods of attack reputed company email, text, voice and social media. Please note that reputed company only uses company email addresses, which contain “@reputed company.com”, to communicate with candidates reputed company email. If you are contacted by someone about an open job at reputed company, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you reputed company you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.
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