Principal Quality System Analyst

Organization: 
Roche
Job Location: 
Branchburg, NJ
Job Description: 

The position

  • •Assist business departments, developing detailed implementation plans for process changes or events (e.g. re-engineered processes, shared services initiatives, or short-term special programs). Assesses and communicates cross-functional impact to affected areas across the operating business departments. Evaluates and facilitates prioritization of system enhancement requests. Works with cross-disciplined members of Operations, Quality Management, Clinical, and Development.
  • •Manages RMS audit programs including internal audits (routine, directed, "audit by walking around"), external audits (e.g. FDA, ISO, Red Cross, etc.) and supplier audit/qualification.
  • •Functions in Lead Auditor capacity including audit preparation, performance, reporting, follow-up and closure.
  • •Constructs, maintains and improves Audit Metrics.
  • •Provides training for and manages activities of the Internal Auditor Team.
  • •Serves as resource providing GMP/Compliance information/consultation.
  • •Assists in providing GMP training for all RMS employees
  • •Manages regulatory audit documentation via Sharepoint.
  • •Provides technical review for RMS SOPs and Processes.
  • •Ensures compliance with corporate and global Roche and Diagnostics standards (e.g. Roche and Diagnostics Core, IT Project Methodology, CSV rules & guidelines).
  • •Provides support for management of external audits (regulatory, customer)
    • •Audit Logistics
    • •Document staging/processing/preparation/management room
    • •Scribe
    • •RMS Response to audit findings identified during external audits
Requirements: 

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

Education:

  • •Required: Bachelor’s degree in science or engineering (including quality engineering) or related field, or equivalent combination of education and work experience.
  • •Preferred: Master’s degree in science or engineering (including quality engineering)


Certifications:

  • •Required: Certified Quality Auditor (CQA) or equivalent.


Job-related Experience:

  • •Required: 5 years in a CBER, CDER or CDRH regulated facility, and experience as Lead Auditor in medical device/pharmaceutical auditing practice.
  • •Preferred: Experience as a Regulatory Agency (FDA) or Notified Body Investigator/Auditor
Contact Information: 

The next step is yours. To apply online today and to learn about other exciting positions, please go to: careers.roche.com and enter Job ID #2554365225 in the “Keyword” box underneath the Global Job Search field. Roche is an Equal Opportunity Employer.

About Our Organization: 

Who we are
At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.