Quality Control Specialist

Client has the option to transition to permanent employment after 6 months.

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

Must have

-Bachelor's degree in Science or Computer Systems

-Minimum 5 years QC support experience in Pharmaceutical or Biotech manufacturing experience.

1. Lead the QC application implementation and integration projects for the Houston Site.

2. Procure, configure, and maintain any computers, instruments, and equipment related to the QC labs.

3. Work together with customer, vendor, local and global teams to configure the application adapting to the local needs and document any application deliverables.

4. Configure instruments and devices related to the implementation of QC systems and applications.

5. Act as system owner of the local QC systems.

Job Type: Contract

Salary: $85.00 - $90.00 per hour

Expected hours: 40 per week

Benefits:

• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Professional development assistance
• Vision insurance

Experience level:

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

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Weekends as needed

Work setting:

• Assembly line
• Factory
• Manufacturing facility
• Office

Application Question(s):

• 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.
• Configure instruments and devices related to the implementation of QC systems and applications

Education:

• Bachelor's (Required)

Experience:

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

Work Location: On the road