PAY: $55-80/hour W2. Our company offers our consultants a suite of benefits after a qualification period including health, vision, dental, life and disability insurance.
Onsite role in San Diego, CA
W2 Candidates only
Position Summary
Onsite role in San Diego, CA
W2 Candidates only
Position Summary
- The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA. In this on-site contracted role, you 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.
- You will ensure compliance with regulatory requirements while supporting site-specific needs. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics. You will collaborate closely with cross-functional GxP partners including QA, QC, Manufacturing, Validation, Supply Chain, Facilities, and Clinical teams.
- 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).
- Support continuous improvement efforts for events within EDMS and LMS.
- Work with document owners to ensure timely periodic review of procedures.
- Assist in the creation and revision of SOPs, policies, forms, templates, and reporting tools.
- Generate and trend quality metrics, communicating findings to leadership.
- Support internal and external audits, including regulatory agency or partner audits, and assist in executing corrective action plans.
- Review and approve paper-based quality documentation and electronic quality records.
- Promote a culture of quality, teamwork, and accountability with a patient-first mindset.
- Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered).
- Minimum of 8 years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred).
- 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).
- Exceptional written and verbal communication skills.
- Strong attention to detail and ability to manage multiple projects simultaneously.
- Proven ability to work independently and collaboratively in a fast-paced, dynamic environment.
- Experience developing training materials and delivering training to employees.
- Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents.
Who We Are:
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.
Browse our website below for additional information on our company.
The Fountain Group
3407 W Martin Luther King Jr. Dr. Tampa, FL 33607
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”
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