Quality Specialist GxP Electronic Systems
Share
Job Location:
Redwood City, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team you will join other outstanding Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Provide Veeva Quality Platform business administration support including configuration support access management and user assistance within validated GxP systems.
Provide administrative support for quality systems including ComplianceWire Inspection Management Systems and DocuSign by coordinating user provisioning overseeing training records generating reports and maintaining system documentation.
Deliver instructor-led classroom training sessions for end users on Quality Platforms functionality and system workflows.
Develop and maintain system reports and interactive dashboards to track key performance indicators (KPIs) and operational metrics.
Support GxP training compliance by ensuring completeness and accuracy of training files including CVs and job descriptions for GxP personnel.
Update and manage internal content on RevMeds intranet site contributing to clear and effective interdepartmental communications.
Execute and document test scripts for configuration changes to validated electronic systems ensuring compliance with quality and regulatory requirements.
Support the development and distribution of information newsletters and communications related to Veeva system configuration updates.
Contribute to internal audit & inspection readiness by gathering records generating reports and ensuring document traceability within the electronic QMS.
Required Skills Experience and Education:
Bachelors degree in Life Sciences or related field (advanced degree preferred)
1-2 years of experience in GxP Quality Assurance within the pharmaceutical biotechnology or related regulated industry.
Demonstrate ability to manage multiple tasks prioritize effectively and meet deadlines.
Excellent written and verbal communication skills.
Proficiency in Microsoft Office Suite (Word Excel PowerPoint and Outlook).
Experience with electronic Quality Management Systems (eQMS) such as Veeva Quality Suite
Ability to work independently and collaboratively across cross-functional teams in a dynamic environment
Preferred Skills:
Familiarity with Document Control Training Compliance Audit Management GxP systems validation within a pharmaceutical quality system.
Experience supporting change management in GxP systems.
A continuous improvement mindset and willingness to take initiative in solving problems.
#LI-Hybrid #LI-JC1
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role level and location. Individual base pay salary is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed which includes competitive cash compensation robust equity awards strong benefits and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital status medical condition and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect process and use any personal data that you provide to us in accordance with ourCCPA additional information please contact.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms email phone or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information purchase equipment or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @ email address.
If you believe youve been contacted by someone impersonating a Revolution Medicines recruiter please report it to so we can share these impersonations with our IT team for tracking and awareness.
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
