Similar posts
Senior Quality Systems Specialist
- Permanent
- Good Manufacturing Practice (GMP)
- United States
This vacancy has now expired. Please see similar roles below...
Proclinical is currently recruiting for a Senior Quality Systems Specialist with a pharmaceutical company located in Redwood City, CA. A successful candidate will have experience with deviations and CAPAs, have a bachelor's degree or higher, and excellent communication skills.
Job Responsibilities:
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements
- Participates in developing Standard Operating Procedures to ensure quality
- Maintains 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
- Supports 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
- Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required
- Supports the maintenance and improvement to quality systems processes, as needed
- Works 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
- Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed
Skills and Requirements:
- Excellent Communication Skills
If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.
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.
#LI-CN1
Related jobs
Highly Competitive Salary
Maidenhead, England
Proclinical is seeking a dedicated QA Associate for our Supply Chain Quality Assurance team. This is a permanent position located in Maidenhead, England.
Highly Competitive Salary
Rochester, USA
Proclinical is seeking a proactive and dedicated individual for a Customer Quality Specialist for a leading pharmaceutical company. This is a permanent position located in Rochester, NY
Highly Competitive
Brussel, België
Proclinical has been retained by a cutting edge, biopharmaceutical company to appoint a Global Head of Quality for their commercial manufacturing sites.
Highly Competitive Salary
Pearl River, USA
Proclinical is seeking a QA Manager-Site Compliance for a global mid-sized consumer healthcare and medical devices company.
US$220000 - US$250000 per annum + Highly Competitive Salary
Mountain View, USA
Proclinical Staffing is seeking a VP Quality to join a cutting-edge biotech company.
Highly Competitive Salary
Zebulon, USA
Proclinical Staffing is seeking a QC Chemist to join an ambitious pharmaceutical company.
Up to US$115000 per annum + Highly Competitive Salary
Philadelphia, USA
Proclinical Staffing is seeking a Quality Control Supervisor to join a cutting-edge biopharmaceutical company.
Highly Competitive Salary
Marietta, USA
Proclinical Staffing is seeking a QC Laboratory Technician to join a cutting-edge biopharmaceutical company.
Highly Competitive Salary
Cambridge, USA
Proclinical is seeking a QA Specialist - Equipment and Computer Systems to join a global biopharmaceutical company.
S$0.00 - S$100000 per annum + Highly Competitive Salary
Singapore River, Singapore
Proclinical are recruiting for a Compliance Officer to join a medical device organisation.