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Clinical QA Auditor

Company: Advanced Clinical
Location: Wilmington
Posted on: June 24, 2022

Job Description:

OverviewWe are currently searching for a skilled professional to join a well-known client's team as a Clinical Quality Assurance Auditor / Specialist in Wilmington, DE. Use your clinical background to ensure clinical trial and study documents adhere to Regulatory standards and audits for upcoming FDA submissions. ResponsibilitiesUse your clinical background to ensure study documents follow regulatory requirements.- Provide operational QA Support for implementation and maintenance of the QMS (Veeva)- Support for Clinical functions for QMS reporting- Support the QA team for QMS improvement activities- Assist/Participate to inspections/ audit and involvement for audit GCP execution, based on experienceDUTIES AND RESPONSABILITIES- Operational QA Support for implementation, improvement and maintenance of the QMS (SOPs drafting and/or review, ensure maintenance up-to-date, implementation into eDMS)- Operational QA Support for the US Clinical functions (Medical Affairs, local Clinical team, ---.) for QMS activities : Participate to development of new SOP for new areas- Assist GCP Regulatory inspection activity (and readiness) related to planned submissions in 2022 - Assist with the implementation and maintenance of the Clinical Quality Management System including QA support for change control, deviations - Participate of development of Quality Metrics/Dashboard for Quality in the Clinical areaREQUIREMENTS- Minimum Bachelor's degree in a science or healthcare related discipline, or similarly conferred degree from a University - 1 to 5 years' experience in a pharmaceutical or bio-pharmaceutical company, with QA role in relation with audit and QMS activities (SOPs devlopment, Deviation management, Change Control).- Experience in the participation of QA activities within an eDMS and eQMS (Veeva preferred) would be an asset. - Audit experience in GCP - Strong written and oral communication skills. To Be a Best-fit Your Strengths Must Include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
  • Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
  • Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.About Advanced ClinicalAdvanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com. Regarding your applicationPlease know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.501901

Keywords: Advanced Clinical, Wilmington , Clinical QA Auditor, Accounting, Auditing , Wilmington, Delaware

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