Job Description

Location: San Diego, CA (Onsite)

Relocation assistance is not provided for this role. Candidates must be able to work from the listed location without relocation support.

Type: Full-Time, Direct Hire

NCC Talent Solutions is proud to partner with a growing CDMO startup in San Diego to identify a Quality Assurance Engineer/Specialist. The Quality Assurance Engineer / Senior Quality Specialist supports the Quality function by executing day-to-day GMP Quality activities and partnering cross-functionally to ensure compliance with FDA, EMA, and ICH GMP regulations .

This role focuses on QA operations, documentation, investigations, and inspection readiness , while contributing to the development and maturation of scalable Quality systems.

Key Responsibilities

GMP Quality Operations

• Execute day-to-day Quality Assurance activities in a GMP-regulated environment
• Support compliance with FDA, EMA, and ICH GMP requirements
• Serve as a Quality partner to Manufacturing, Facilities, Engineering, and Operations
• Escalate quality risks, trends, and issues to the Head of Quality as appropriate

Quality Systems & Documentation

• Author, review, and support approval of GMP documentation including:
• SOPs, work instructions, and controlled forms
• Deviations, CAPAs, and change controls
• Risk assessments and investigation reports
• Maintain accurate, inspection-ready Quality records
• Support ongoing development, maintenance, and improvement of the Quality Management System (QMS) under the direction of the Head of Quality

Manufacturing, Facilities & Engineering Support

• Provide QA oversight and support for:
• GMP manufacturing activities and batch record review
• Equipment, facility, and utility qualification and validation activities (IQ/OQ/PQ)
• Cleanroom and aseptic processing environments
• Review and support Quality assessment of changes related to equipment, facilities, and processes
• Collaborate with Facilities and Engineering to ensure GMP expectations are met during maintenance, upgrades, and expansions

Deviations, CAPA & Continuous Improvement

• Lead or support deviation investigations and nonconformance assessments
• Perform root cause analysis and support development and tracking of CAPAs
• Monitor effectiveness of corrective and preventive actions
• Identify trends and contribute to continuous improvement initiatives

Training & Inspection Readiness

• Support GMP training activities and training record compliance
• Assist in preparation for:
• Regulatory inspections
• Customer audits
• Internal and self-inspections
• Participate in audits and inspections as a Quality representative, with guidance from the Head of Quality

Qualifications

Required

• Bachelor’s degree in pharmacy, natural sciences, biotechnology, engineering , or a related discipline (or equivalent experience)
• 3–7+ years of experience in Quality Assurance within a GMP-regulated pharma, or CDMO environment
• Experience supporting aseptic processing, cleanroom operations, or sterile manufacturing
• Hands-on experience with; Deviations, CAPAs, and change control, GMP documentation systems, FDA, EMA, and ICH GMP regulations
• Experience working cross-functionally with Manufacturing, Facilities, Engineering, and Operations
• Strong written and verbal communication skills in English

Preferred

• Exposure to bioprocessing, production, or analytical environments
• Experience supporting facility start-ups, expansions, or scale-up activities
• Participation in regulatory inspections or customer audits
• Comfort working in early-stage or high-growth organizations

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