Quality Associate III/QA Computer Systems Validation Specialist
Company: Tailored Management
Location: Durham
Posted on: November 3, 2025
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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
Keywords: Tailored Management, Durham , Quality Associate III/QA Computer Systems Validation Specialist, Engineering , Durham, North Carolina
