NCC Talent Solutions, LLC · 6 days ago
Quality Assurance Specialist/ Engineer
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$85K/yr - $100K/yr
3+ years expNCC 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/Specialist supports the Quality function by executing day-to-day GMP Quality activities and ensuring compliance with FDA, EMA, and ICH GMP regulations.
Management Consulting
Hiring Manager
Nicole Contreras, SPHR
Responsibilities
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
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
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
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
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
Qualification
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
Company
NCC Talent Solutions, LLC
At Nicole Contreras Consulting, we partner with organizations to transform their Talent Acquisition function into a true strategic advantage.
0-1 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase