Quality Assurance Specialist

Quality Assurance Specialist

We are seeking a dedicated Quality Assurance Specialist for a contract position in Sacramento, CA. This role is crucial in managing quality systems such as production records and deviation systems. The position requires managing deviations, change control, corrective and preventive actions (CAPA), and document management. This is an opportunity to contribute to the development of next-generation cell therapies.

Oversee the management of quality systems including deviations, change controls, CAPAs, and document control.

Ensure that all deviations are thoroughly investigated and resolved, with root causes identified and corrective actions implemented.

Review and approve change controls to ensure compliance with regulatory requirements and internal procedures.

Maintain and improve CAPA processes to resolve quality issues effectively.

Evaluate batch records to make informed batch release decisions.

Collaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release.

Monitor and document any quality issues related to batch production and implement corrective measures.

Maintain the document management system to ensure accuracy and compliance.

Conduct regular reviews of quality documentation to ensure adherence to protocols.

Stay informed of current regulations and industry trends in pharmaceutical quality assurance.

Assist in audit preparations, ensuring quality systems and documentation are audit-ready.

Provide training and guidance on quality systems and compliance requirements.

Foster a culture of quality within the organization.

Participate in continuous improvement initiatives to enhance quality systems and processes.

Identify areas for improvement and suggest appropriate solutions.

Track completion of quality records and maintain metrics.

Work collaboratively with cross-functional teams to support the overall quality of cell therapy products.

Bachelor's degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 3+ years of experience in quality control testing or GMP.

Master's degree in relevant scientific disciplines with 1+ years of experience.

Understanding of FDA regulations, GMP compliance, and quality system processes.

Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred.

Strong organizational skills and ability to manage multiple tasks concurrently.

Detail-oriented with a commitment to data integrity and accuracy.

Ability to work independently and collaboratively in a fast-paced and regulated environment.

Prior experience in internal audits and document control management.

This is a Contract position based out of Sacramento, CA.

The pay range for this position is $30.00 - $50.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Sacramento, CA.

This position is anticipated to close on Aug 31, 2026.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S.,…