Quality Assurance Specialist | Clinical ResearchPosition Summary:As a Quality Assurance Specialist you will review and confirm procedures, track and follow up on commitments and participate in audits and investigations. Tracking Compliance metrics and overseeing vendor qualification and status. Description :
Participates in audits, CAPA’s, and investigations.
Performs internal audits and effectiveness checks.
Reviews SOP, job aids, and other documents for accuracy and completeness.
Evaluate & determine current regulations related to Clinical Research against site SOP’s and processes.
Participates in Computer System Validation (CSV) efforts.
Skills & Qualifications:
3+ years experience in with Quality Assurance in cGxP regulated environment.
Excellent communication skills & experience writing, verifying, and validating SOPs/departmental processes.
Excellent reporting writing skills & ability to adhere to strict timelines.
Preferred Qualifications:
Experience within a clinic, hospital, pharmaceutical, or similar type environment.
Experience responding to audits by sponsors and government agencies.
Computer System Validation experience.
Experience with conducting and/or evaluating CAPA’s and investigations.
Experience with Quality Management Systems (QMS) such as MasterControl.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.