Job Description

Job Title: Quality Associate III/QA Computer Systems Validation Specialist
Location: Campus-USA-RTP-5000 Davis Drive?, NC - 27709
Contract Length: 11+ months (potential for extension or permanent hire)
Pay Rate: $69.94 - $81.90/hour on W2
Benefits: Weekly pay, Medical, Dental, and Vision coverage
Overview:
Assessing the status of computer systems compliance for all GxP manufacturing and supporting processes in connection with the implementation of Syncade Manufacturing Execution System (MES).
This position will be based on-site at an operational pharmaceutical facility in Raleigh, NC. Initially a 6-month contract with a possibility of extension dependent on project needs and colleague performance:

• Mon - Fri, standard work weeks and hours with occasional overtime as needed.
• Regular interaction with project teams, contractors, and site operations staff
• Ability to work in an open office environment with frequent distractions.
• Ability to work within a matrix team is required.

Job Responsibilities:
- Supporting the Large-Scale Manufacturing (LSM) Modernization project for bringing a new Manufacturing Execution System (MES) to the drug substance manufacturing area.
- There will be several phases covering electronic equipment tracking, electronic batch records and release by exception functionalities.
- Support the quality engineering workstream and activities associated with ensuring the site is ready to receive this change and sustain it within routine production operations.
- Review and provide support for the execution and documentation of the CSV Program at the RTP facility in support of all aspects of the Computer Systems Validation (CSV) Lifecycle.
- CSV activities:
MUST HAVE 2+ YEARS MES EXPERIENCE
1) documentation requirements
2) reports including plans, risk assessments
3) function requirements
4) configuration specifications
5) testing
6) change controls
7) traceability matrix
8) qualification protocols
9) validation and compliance reviews.
- Ensure communication of project deadlines and performance standards for the Quality team are met.
- Respond to inquiries from management, and end users and provide status updates on a frequent basis.
- Plan, contribute and collaborate on CSV activities.
- Keep current of regulatory requirements that may have an impact on CSV.
- Review and approval of computer systems in the field including manufacturing and automation systems.
- Work with Automation Engineering and system owners to resolve deviations that occur during testing activities.
- Information will be communicated to the Senior Manager of Quality Engineering.
#TMN

Skills Required