Iovance Biotherapeutics - Clinical QA Specialist II, Clinical Specialist Providers (CSP)
Requirements
• Required Education, Skills, and Knowledge • BS in life sciences or equivalent experience • 5 + years of overall GCP or QA experience including 2 + years in service provider oversight • Strong interpersonal, written and oral communication skills • Exceptional organizational and critical thinking skills • Must be able to build partnerships and diplomatically work with other departments • Proficiency in the use of relevant computer systems including MS office • Physical Demands and Activities Required • Must be able to remain in a stationary position standing or sitting for prolonged periods of time • Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. • Must have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading • This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers • Must be able to communicate with others to exchange information • Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, administration, critical thinking and task prioritization skills, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines • Mental • Work Environment • Work Environment • This job operates in a remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards. • The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills. • Pay Transparency • $110,000—$120,000 USD • The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. • Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact [email protected]. • By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
Responsibilities
• Maintenance of the CSP qualification/requalification and oversight programs • Completion of service provider qualification/requalification activities for a variety of CSPs (CROs, laboratories, imaging services, ethics committees, computer systems/software, etc.) • Risk identification and mitigation for CSPs • Service provider oversight from a CQA perspective, including interventions when the service provider is not performing as required (manage quality events, non-compliances, CAPAs, serious breaches, CSPCARs, etc.), and quality agreement negotiations • Provide representation at study management team and CSP meetings • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics • Perform miscellaneous duties as assigned • Travel
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