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Senior Quality Assurance Specialist

The Fountain Group LLC

South San Francisco, CA

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JOB DETAILS
SKILLS
Biology, Biotech and Pharmaceutical, Change Control, Clinical Facilities, Communication Skills, Consulting, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Management, Document Control, Document Management, Documentation, External Audit, GCP (Good Clinical Practices), GMP (Good Manufacturing Practices), Gene Therapy, GxP, Healthcare Quality, Internal Audit, Leadership, Learning Management System (LMS), Maintain Compliance, Manufacturing, Medical Products, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Quality Assurance, Quality Control, Quality Management, Quality Metrics, Quality Monitoring, Record Keeping, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Dashboards, Standard Operating Procedures (SOP), Supply Chain, System Integration (SI), System Migration, Systems Maintenance, Team Player, Time Management, Training Program, Training/Teaching
LOCATION
South San Francisco, CA
POSTED
30+ days ago
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.
 
Key Responsibilities:
  • 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.
 
Qualifications:
  • Education: Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered).
  • Experience: Minimum of 5 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).

About the Company

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The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/