Role Overview:
As the Quality Control Business Analyst for Operations Support, you will spearhead the implementation and integration of QC applications at the Houston Site. Your responsibilities will include procuring, configuring, and maintaining all computers, instruments, and equipment essential for QC labs. Collaborating closely with customers, vendors, and both local and global teams, you will configure applications to align with local requirements and diligently document all deliverables. Additionally, you will act as the system owner for local QC systems and author operational handbooks and SOPs.
Key Responsibilities:
- Lead QC application implementation and integration projects at the Houston Site.
- Procure, configure, and maintain computers, instruments, and equipment for QC labs.
- Collaborate with stakeholders to configure applications and adapt to local needs, ensuring thorough documentation.
- Configure instruments and devices crucial for QC system implementation.
- Act as the system owner for local QC systems, responsible for operational documentation and user management.
- Provide comprehensive support for QC applications, including system periodic reviews and on-site user training.
- Proactively identify and address potential issues, implementing necessary corrective actions.
- Stay updated on automation information systems methodologies and introduce innovations with minimal supervision.
- Investigate and troubleshoot increasingly complex technical problems related to QC system interfaces.
- Contribute to the design and implementation of new applications/solutions to enable seamless integration of QC instruments.
- Ensure compliance with 21 CFR Part 11 regulations and maintain system integrity, seeking performance and security enhancements.
Projects:
- Assist in planning and executing integration projects for computerized systems changes and process improvements in the QC lab.
- Execute test scripts with supervision, own change requests, and perform change request assessments.
Deviations / Root Cause Analysis:
- Aid the Quality department in deviation investigations and completion of CAPA actions.
- Provide technical input on QC lab systems deviations and participate in quality risk assessments.
Documentation:
- Review and revise SOPs, Functional Specifications, and work instructions, incorporating feedback from CAPA, equipment/process changes, etc.
- Develop, test, and maintain disaster recovery/application procedures.
Training:
- Stay current on assigned training activities, including SAP Learning Portal, Compliance Wire, iComply, and QSMRT.
- Provide training to end users.
Requirements:
- Bachelor's degree in Science or Computer Systems.
- Minimum 5 years of QC support experience in Pharmaceutical or Biotech manufacturing.
- Prior experience in Automation/MES systems development and integration.
- Fluent in English.
- Strong analytical skills to relate and compare data from various sources and identify cause-and-effect relationships.
- Ability to evaluate engineering problems and propose effective solutions.
- Proficiency in procuring, configuring, and maintaining QC lab equipment and instruments.
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