Quality Control Business Analyst (W2 Only)

Willing to work on W2

Operations Support

• Lead the QC application implementation and integration projects for the Houston Site.
• Procure, configure, and maintain any computers, instruments, and equipment related to the QC labs.
• Work together with customers, vendors, and local and global teams to configure the application, adapt to the local needs, and document any application deliverables.
• Configure instruments and devices related to the implementation of QC systems and applications.
• Act as system owner of the local QC systems.
• Author of QC Systems Operational Handbook, User Management, Periodic Reviews/Maintenance, and Disaster Recovery SOPs.
• Responsible for the QC applications support (including system periodic reviews).
• Provide on-site support and training to system users.
• Proactively recognize potential issues or problems and establish the necessary corrective actions.
• Provide after-hours support as needed to resolve issues outside of normal business hours.
• Continuously aware of new methodologies related to automation information systems and is able to introduce them with limited supervisory input.
• Investigates and troubleshoot technical problems of increasing complexity related to QC system interfaces.
• Utilizes system documentation to solve complex problems.
• Contribute to the design and implementation of new applications/ solutions related to the integrations of QC instruments to QC applications/systems to enable data transfer.
• Understand and comply with 21 CFR Part 11 regulations.
• Maintains system integrity and seeks performance and security improvements.

Projects

• Assist with the planning and execution of integration projects involving computerized systems changes and process improvements for the QC lab.
• Execute test scripts (design, execution, simulation, etc.) with support and guidance from the supervisor.
• Own change requests and complete change request tasks to support project completion.
• Perform change request assessments.

Deviations / Root Cause Analysis

• Assist the Quality department with deviation investigations
• Assist with the completion of CAPA actions
• Provides technical input of QC lab systems deviations
• Participates in quality risk assessments

Documentation

• Review/revise OIS and manufacturing-related SOPs, Functional Specifications, and work instructions as a result of CAPA, equipment/process changes, error prevention activities, etc.
• Review work orders generated by OIS
• Develop, test, and maintain disaster recovery/application procedures

Training

• Remain up to date on all assigned training activities including SAP Learning Portal (>95%),
• Compliance Wire (no overdue), iComply (no overdue), and QSMRT (attend all sessions)

Provide training to end users

Job Type: Contract

Pay: $80.00 - $85.00 per hour

Expected hours: 40 per week

Experience level:

• 10 years
• 6 years
• 7 years
• 8 years
• 9 years

Schedule:

• 10 hour shift
• 8 hour shift
• Monday to Friday

Experience:

• QC support in Pharmaceutical or Biotech manufacturing: 5 years (Required)

Ability to Relocate:

• Houston, TX: Relocate before starting work (Required)

Work Location: In person