Onsite: San Diego

About Us

• Based in San Diego, our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure.
• We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single-treatment cures for patients in need.

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.

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.
• Align daily activities with department goals and company values.
• Ability to lift up to 20 pounds as needed.

Qualifications

• Education: Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered).
• Experience: Minimum of 8 years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred).

Technical Skills:

• 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).

Competencies:

• 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.

The hiring range for this position is $50 to $60 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.

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