Quality Assurance Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)
  3. United States
Cambridge, USA
Posting date: 12 May 2021

Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Cambridge, MA.

Job Responsibilities:

  • Assist in the maintenance of GCP and GVP quality systems, particularly those that interface with Deviations, CAPAs, and Audits.
  • Maintain and assist in the development and reporting of quality metrics, particularly those pertaining to Deviations, CAPAs, Effectiveness Checks, training compliance, and documentation.
  • Build, develop, and maintain good working relationships with internal and expertise areas.
  • Timely data management of internal and external audit records, including timely communication with vendors to support closure or extension audit content.
  • Work with internal GCP and GVP customers and develop and execute strategic audit activities under the guidance of Quality management.
  • Provide support for Investigator Site audits
  • Participate in company preparations for regulatory inspections.
  • Participate in cross-functional quality system initiatives representing GCP/GVP QA

Skills and Requirements:

  • Up to 2 years of experience in a biotech or pharmaceutical environment.
  • Ability to work consistently, flexibly, and adjust to changing priorities in a fast-paced environment.
  • Excellent attention to detail and time management skills in the context of managing multiple priorities with aggressive timelines.
  • Educated to degree level, preferably life science (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification.

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

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.