QA Specialist

  • Permanent
  • Anywhere

Website Actalent


Company : Actalent

Country: United States

Location : Rockville, Maryland

Post: Sun, 19 Sep 2021 05:27:41 GMT

Expires: Tue, 19 Oct 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

DESCRIPTION:Responsibilities * Ensure compliance with project-specific Quality Management Plan (QMP) * Conduct protocol audits of CRID studies * Support client and regulatory audits and inspections of CRID studies * Develop, implement, and report on corrective and preventative action plans (CAPAs), as necessary * Implement and maintain a quality metrics database for quality metrics reporting * Report on quality assurance activities and quality metrics to the project management and sponsor * Promote the use of standard and approved templates for study materials and reports * Develop processes and tools for quality control of project deliverables and reports * Contribute to CRID project-specific policies, procedures, and plans * Advise on project processes and develop plans for continuous quality improvement SKILLS:QA Audit, QA Management, Clinical Research, Regulatory AffairsTOP SKILLS DETAILS:QA Audit, QA Management, Clinical ResearchADDITIONAL SKILLS & QUALIFICATIONS: * Bachelors degree and 6 years related experience or Masters degree and 4 years related experience, and demonstrated working knowledge of scientific principles appropriate to the position. * Excellent oral and written communication skills. * Strong interpersonal skills and ability to deal with staff at all levels with sensitivity and tact. * Experience with developing and implementing quality processes in clinical trials * Demonstrated ability to foster concepts of teamwork, research integrity, ethical conduct and personal responsibility. * Ability to self-direct and work independently and in a complex team environment. * Knowledge of clinical research including the critical elements for the development and execution of clinical trials or research studies. * Strong skills in prioritization, organization, problem solving, decision-making, time management, mentoring and planning. EXPERIENCE LEVEL:Intermediate Level ABOUT ACTALENT: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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