Senior Regulatory Compliance Specialist
OneTrust
full-time
Posted on:
Location Type: Office
Location: San Jose • California • United States
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Job Level
About the role
- Responsible for maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements.
- Responsible for the data analysis and reporting for the sites and identify compliance issues.
- Lead, participate and/or support as needed in projects associated with audit process and application for the sites.
- Complete statistical analysis of data for decision making.
- Review of manufacturing processes, instrument and equipment qualifications, (IQ/OQ/PQ), design history file, engineering documentation, etc.
- Supports external audits and mock inspections: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site.
- Ensures adequate corrective actions for internal audits, including robust root cause investigations and corrective action plans, drive on-time completion of observation action plans, perform follow-up with observation owners.
Requirements
- Generally requires 5 Years Work Experience
- Bachelor’s degree or equivalent required; concentration in Engineering or technical field preferred.
- Bachelor’s degree or equivalent with 4 - 6 years of experience in a FDA regulated industry (pharmaceutical or medical devices) or another highly regulated industry is required.
- Experience in Quality, Manufacturing or Engineering roles will be preferred.
- Experience leading internal quality system audits is preferred.
- Experience leading or managing an internal audit program is preferred.
Benefits
- health insurance
- retirement plans
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data analysisstatistical analysiscompliance program managementaudit processinstrument qualificationequipment qualificationroot cause investigationcorrective action planning
Soft Skills
leadershipcommunicationorganizational skillsproblem-solving