Quality Assurance Specialist

Job Description

Job Description

.Kelly® Science & Clinical is seeking a Quality Assurance Specialist for a 6-month contract opportunity with one of our clients, a biotechnology company in South San Francisco that has pioneered cell therapy manufacturing solutions. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Position type: 6-month contract
Workplace: Onsite in South San Francisco, CA
Pay Range: $40-42 per hour
Are you passionate about bringing the next generation of cell therapies to patients and ensuring the highest standards of product quality? We are seeking a dedicated and detail-driven Quality Assurance Specialist to join a leading, mission-focused biotechnology company dedicated to advancing cell therapy manufacturing. This is a contract position employed via a staffing partner, and you will play a critical role onsite in South San Francisco as part of our dynamic team.
About the Opportunity
As a Quality Assurance Specialist, you will directly support ongoing manufacturing operations, serve as a key resource for quality on the production floor, and help drive compliance and continuous improvement across cGMP operations. This hands-on role offers the unique opportunity to gain comprehensive experience in quality operations, documentation management, deviation handling, and cross-functional collaboration, all within an innovative and fast-paced environment at the forefront of cellular therapeutics.
Responsibilities

• Provide real-time QA support to day-to-day manufacturing activities, ensuring operations are executed in alignment with approved Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGxP).
• Review batch records, production logs, and associated documents for accuracy, completeness, and compliance with cGMP requirements.
• Support the identification, documentation, and investigation of deviations and quality events, including root cause analysis and timely resolution.
• Assist with the review and release of raw materials for manufacturing.
• Conduct routine QA walkthroughs of the manufacturing floor, escalating and addressing quality events as appropriate.
• Manage document control processes, including the review and routing of SOPs and related quality documentation.
• Participate in change control processes and contribute to continuous improvement activities.
• Oversee quality status for in-process and finished product, including coordinating shipping documentation and release readiness.
• Support the identification and remediation of non-compliance to cGMP and Good Documentation Practices (GDP).
• Perform other QA-related tasks as needed to support the success of the team and the organization.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Quality Assurance, or a related field.
• 1-5 years of quality management or quality assurance experience within a regulated industry such as pharmaceuticals, biotechnology, medical devices, or cell & gene therapy.
• Solid understanding of cGMP regulatory standards—FDA, EMA, ICH guidance preferred.
• Familiarity with quality management systems and GDP requirements in a GMP environment.
• Experience in cell therapy or cell-based processing is a strong advantage.
• Strong communication, organizational, and analytical skills, with the ability to thrive in a high-energy, fast-changing setting.
• Team-oriented mindset with the ability to work independently and engage collaboratively across multiple functions.
• Demonstrates integrity, self-awareness, authenticity, and a proactive, entrepreneurial approach.

Preferred

• Hands-on experience with TrackWise Digital electronic QMS, LabVantage, and SAP is highly desirable.

If you are eager to contribute to the advancement of transformative cell therapies and to make a meaningful impact on patient lives, we encourage you to apply today. Join an organization where your expertise will shape the future of cellular medicine!

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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