Senior QA Operations Specialist - GMP Compliance & Impact

Neurocrine Biosciences; San Diego (CA); On-site; USD 97,000 - 133,000; Full time

Benefits offered by this job

Annual bonus

Equity-based LTIP

401(k) match

PTO

Health insurance

Dental/vision

Job summary

Neurocrine Biosciences is seeking a Sr. Specialist of QA Operations to provide quality support for GMP manufacturing under general supervision. The role involves reviewing quality records, dispositioning GMP products, and leading deviation investigations.

This position requires strong collaboration with CMOs, auditors, and internal QA teams. Ideal candidates have a BS/BA or Master’s in Life Sciences or related field with 2–4+ years of QA experience in pharma/biotech, excellent communication, and

Qualifications

• BS/BA degree in Life Sciences, Engineering, or related field with 4+ years of quality experience in pharma/biotech OR Master’s degree with 2+ years of similar experience
• Works well in a team environment
• Ability to work closely with internal and external personnel
• Strong organizational and time management skills
• Ability to meet multiple deadlines with accuracy and efficiency
• Attention to detail and critical thinking
• Strong written and verbal communication skills
• Ability to quickly assess new information and communicate requirements
• Knowledge of FDA and EU CGMP regulations and ICH Guidelines
• Experience reviewing quality records for GMP manufacturing
• Ability to escalate problems and drive corrective actions
• Experience with investigation methodologies
• Experience with electronic quality management systems

Responsibilities

• Review quality records related to GMP products manufactured by CMOs for CGMP compliance
• Dispostion of GMP products per regulations and procedures
• Participate in project teams as QA representative and escalate issues
• Provide QA support for NPI processes and substantial changes
• Interface with stakeholders to process quality records and resolve issues
• Lead or participate in deviation investigations
• Participate in change control for clinical or commercial products
• May participate in external supplier audits and inspections
• Support other Quality functions to ensure compliance and continuous improvement
• Other duties as assigned

Education

BS/BA degree in Life Sciences, Engineering, or related field

Master’s degree in Life Sciences, Engineering, or related field

Job description

Neurocrine Biosciences is seeking a Sr. Specialist of QA Operations to provide quality support for GMP manufacturing under general supervision. The role involves reviewing quality records, dispositioning GMP products, and leading deviation investigations.

This position requires strong collaboration with CMOs, auditors, and internal QA teams. Ideal candidates have a BS/BA or Master’s in Life Sciences or related field with 2–4+ years of QA experience in pharma/biotech, excellent communication, and