Quality Auditor II

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United States
Boston, USA
Posting date: 05 Sep 2019

Proclinical is currently recruiting for a Quality Auditor for a CRO company located in Boston, MA. Successful candidate will be responsible for internal, supplier, client and SOC audits. The Quality Auditor initiates and implements quality improvement activities as appropriate to raise performance of the company services, systems and employees; additionally, he/she guides, mentors as well as trains company employees regarding their impact on the QMS and implementation of audit findings and process improvements.

Job Responsibilities:

  • Manage and coordinate sponsors audits including quality, privacy, security and 21 CFR Part 11 assessments.
  • Manage and perform internal audits and hosting/supporting client audits.
  • Manage and coordinate preparation for and hosting of SOC 2 Type 2 and client audits.
  • Provide quality oversight for critical business projects including enterprise clients' initiatives.
  • Support company-wide Corrective and Preventive Actions (CAPA) program.
  • Consult project teams on resolution of audit findings, quality management and validation deliverables.
  • Facilitate quality related internal project team meetings and calls.
  • Conduct and support calls with customer auditors and quality representatives.
  • Supporting project teams during quality related sponsor meetings and calls.

Skills and Requirements:

  • BA/BS in science or business, MA/MS preferred.
  • 5+ years of quality, computer systems/software validation, audits and project management experience.
  • Strong interpersonal and communication skills (both written and verbal).
  • Understanding clinical trials.
  • Knowledge and experience with 21CFR Part 11 and GXP.
  • Knowledge and experience of Agile SDLC and system validation.
  • Ability to work in a global team environment and excellent problem-solving skills.
  • Focus on quality, results and orientation toward accomplishing strategic organizational goals.
  • Excellent project management skills.
  • Ability to handle multiple, rapidly changing and sometimes conflicting priorities.
  • Prior experience performing client, suppliers and/or internal audits.
  • Prior experience with quality management systems in regulated environment of CRO, pharma and/or medical device companies.
  • Strong PC skills (i.e. Microsoft Office).
  • High energy, self-starter with the ability to work in a global team environment.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Ysabel Capitan (+1) 347-293-1123 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.