Quality Systems Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP)
  3. United States
Philadelphia, USA
Posting date: 02 Feb 2021

Proclinical is currently recruiting for a Quality Systems Specialist with a pharmaceutical company located in Philadelphia, PA.

Job Responsibilities:

  • Quality system administrator for the electronic Quality Management System, including establishing, implementing, validating and administering policies and procedures.
  • Provides guidance and education to personnel on Quality Management procedures and policies and on quality regulations.
  • Maintains the electronic Quality Management System, ensuring the Quality procedures are in place and performing routine maintenance and updates within the system.
  • Writes and revises quality/other procedures and policies, as needed to ensure regulatory compliance.
  • Participates in external regulatory/accreditation agency inspections, as required.
  • Able to provide customer service to end users and help them resolve any issues or questions with the electronic system

Skills and Requirements:

  • Bachelor's degree in science or another scientific discipline
  • 3 years minimum relevant experience in a Quality-based role
  • Previous experience with electronic document control system
  • Previous experience in the use of different Quality Management software packages (i.e. Pilgrim, Trackwise, Master Control)
  • Experience with Laboratory Information Management Systems (LIMS) and Asset Management Systems
  • Knowledge of data management tools for querying and summarizing data for writing reports. i.e. Access, Excel
  • Experience with electronic document control, change controls, CAPAs, deviations, audit management, vendor management, and training/competency software applications a plus

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.