Quality Systems Specialist
Proclinical is currently recruiting for a Quality Administrator for a global biotechnology company located in Philadelphia, PA. Successful candidate will support the day-to-day document control activities for North and South America and Asia Pacific.
- Perform a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Participate in developing Standard Operating Procedures to ensure quality.
- Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
- Independently conduct, complete, and document critical, major, and minor investigations related to GxP operations.
- Facilitate cross-functional meetings with internal and external parties as required.
- Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions.
- Support management and tracking of quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets.
- Responsible for maintaining tracking tools/databases.
- Responsible for sending periodic reminder notifications to leads/coordinators.
- Support management review process through development and generation of quality system metrics and trending, and escalate issues as required.
- Support the maintenance and improvement to quality systems processes, as needed.
- Work directly with operating entities and internal clients to ensure follow-up of quality issues.
- Participate in the development of training programs regarding all aspects of producing quality products, as required.
- Assist compliance audits as required.
- Write and/or implement changes to controlled documents as needed.
Skills and Requirements:
- Bachelor's degree and former pharmaceutical experience preferred
- 3-5 years of working experience
- Excellent writing and verbal communication skills
- Deviation, investigation, and CAPA experience
- Root cause analysis experience
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 Brendan Thalheimer at (+1) 215-531-5299 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.