Quality Assurance Specialist

Job Description


Responsibilities

• Support and maintain the Quality Management System (QMS).
• Conduct reviews of batch records, manufacturing documentation, and quality records.
• Assist with internal audits, supplier audits, and regulatory inspections.
• Manage and investigate deviations, non-conformances, and corrective/preventive actions (CAPAs).
• Review and approve SOPs, work instructions, and controlled documents.
• Monitor compliance with GMP, GLP, FDA, and applicable regulatory requirements.
• Collaborate with Manufacturing, R&D, Operations, and Regulatory teams to ensure quality standards are met.
• Participate in risk assessments and process improvement initiatives.
• Maintain training records and support employee quality training programs.
• Generate quality reports, metrics, and trending analyses.
• Assist with product release activities and quality reviews.

Qualifications
Required:

• Bachelor's degree in Biology, Biotechnology, Chemistry, Life Sciences, or a related field; equivalent experience may be considered.
• 2+ years of Quality Assurance experience in biotechnology, pharmaceutical, medical device, laboratory, or other regulated environments.
• Knowledge of GMP, GLP, FDA, ISO, or related quality standards.
• Strong documentation, organizational, and problem-solving skills.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office Suite.

Preferred:

• Experience with electronic quality management systems (eQMS).
• Audit or CAPA management experience.
• Knowledge of regulatory inspections and compliance requirements.
• Experience supporting laboratory or manufacturing operations.

Skills

• Quality Assurance
• GMP & GLP Compliance
• CAPA Management
• Document Control
• Internal Auditing
• Regulatory Compliance
• Root Cause Analysis
• Risk Assessment
• Quality Management Systems
• Data Review & Reporting
• Process Improvement

Apply Today

If you are passionate about quality and compliance and want to help advance biotechnology solutions that improve lives, we encourage you to apply.

Job Type: Full-Time

Schedule: Monday-Friday, 8:00 AM-5:00 PM

Location: Davis, CA

Compensation: $26.00-$45.00 per hour, depending on experience and qualifications.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.


Job Reference: JN -102026-432272