Quality Specialist II, Quality Systems

Thermo Fisher Scientific • Carlsbad, CA

4d • $66,000 - $88,000 • Onsite

About The Position

As a Quality Specialist II, as part of 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 be part of the quality systems organization, supporting various quality processes and initiatives, and helping to ensure the effectiveness of the Quality Management System (QMS).

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

Nice To Haves

• Travel may be required occasionally to support quality-related activities

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

Benefits

• A choice of national medical and dental plans, and a national vision plan, 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 in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level