GxP Quality Assurance Consultant

GxP Quality Assurance Consultant ROCGJP00039852

• Hourly pay: $60/hr
• Worksite: Leading biotechnology company (San Diego, CA 92121 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 6 Month Assignment

A leading biotechnology company is seeking a GxP Quality Assurance Consultant for their clinical-stage biopharmaceutical facility that creates next-generation cell and gene therapies with the capacity to cure, making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. The QA Consultant will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions.

GxP Quality Assurance Consultant Responsibilities:

• Ensure compliance with regulatory requirements while supporting site-specific needs.
• Support concurrent activities for legacy Quality systems during QMS integration and system migration phases.
• Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems.
• Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls.
• Operate and support legacy Quality systems during the transition to new platforms.
• Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records.
• Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA).
• Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records.
• Perform operational functions within the ComplianceWire Learning Management System (LMS) and Qualio (EDMS).

GxP Quality Assurance Consultant Qualifications:

• 8+ years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred).
• Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered).
• Strong knowledge of Quality Management Systems in a cGxP manufacturing environment.
• Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.
• Hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) such as ComplianceWire or Qualio.
• Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).
• Strong attention to detail and ability to manage multiple projects simultaneously.
• Experience developing training materials and delivering training to employees.
• Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents.
• Ability to lift up to 20 pounds as needed.

Shift:

• Standard hours 8am to 5pm - may need to have some flexibility to work earlier/late as needed.