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Quality Systems Specialist
- Permanent
- Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP)
- United States
This vacancy has now expired. Please see similar roles below...
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.
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