Quality Specialist II, Quality Systems

This is a fully onsite position based at our Carlsbad, CA site. Priority will be given to local candidates currently residing in San Diego County or South Orange County area. Must be legally authorized to work in the United States without sponsorship now or in the future. Must be able to pass a comprehensive background check, which includes a drug screen.

About the role

As a Quality Specialist II within Quality Systems at our Carlsbad site—an RUO (Research Use Only) manufacturing facility—you will play an important role in maintaining compliance with quality standards and regulations specific to RUO product manufacturing. You will support various quality processes and initiatives, ensuring the effectiveness of the Quality Management System (QMS).

Responsibilities

• Assist in managing customer inquiries related to product quality and compliance
• Manage customer quality agreements and change notification agreements
• Support the preparation and maintenance of compliance-related documentation
• Contribute to Change Management processes, ensuring adherence to regulatory requirements
• Participate in investigations and Corrective and Preventive Actions (CAPAs) related to quality issues
• Assist with Internal and External Audits by helping to prepare documentation
• Support compliance activities and initiatives under the guidance of senior team members
• Help monitor the QMS to ensure its proper functioning and identify areas for improvement
• Collect data for site metrics, contributing to continuous improvement initiatives
• Support quality system projects as assigned

Requirements

• Bachelor's degree in a scientific field such as Chemistry, Biology, or related discipline
• 2–4 years of experience in quality assurance or quality control in a regulated industry, preferably in RUO or similar research product manufacturing
• Knowledge of quality management systems, regulatory requirements, and compliance standards applicable to RUO product manufacturing
• Familiarity with quality documentation types and processes
• Basic understanding of change management processes
• Experience in handling customer inquiries related to quality and compliance
• Experience in deviation investigations, CAPA, and root cause analysis tools
• Basic proficiency in data analysis and quality metrics reporting
• Good organizational skills with the ability to manage multiple tasks
• Analytical and problem-solving abilities
• Strong written and verbal communication skills
• Proficiency with quality management software and Microsoft Office applications
• Ability to work collaboratively in a team environment
• Detail-oriented with a commitment to quality and compliance
• Adaptability to changing priorities
• Willingness to learn and grow within the quality assurance and compliance field
• Occasional travel may be required to support quality-related activities

Pay

The salary range estimated for this position based in California is $66,000.00–$88,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits

• A choice of national medical, dental, and vision plans, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offering the opportunity to purchase company stock at a discount

Schedule

Standard (Mon–Fri)