Senior QA Lead - CAPA & Compliance (Healthcare)

Grifols; San Diego (CA); On-site; USD 108,000 - 140,000; Full time

Benefits offered by this job

Bonus pool up to 8%

Job summary

Grifols is seeking a Senior Quality Assurance Specialist in San Diego to manage nonconformances, CAPA records, and audits. The role drives quality improvements through data analysis, cross-functional collaboration, and risk assessments.

Responsibilities include leading quality meetings, reviewing manufacturing documents, mentoring staff, and coordinating regional QA activities. A BA/BS in a related field with 5–8 years of experience is preferred, with ASQ certification a plus.

Qualifications

• BA/BS in biology, chemistry, biochemistry or biomedical engineering.
• Quality certification (ASQ or equivalent) is a plus.
• 5–8 years quality experience in nonconformances, CAPAs, audits and OOT.

Responsibilities

• Investigate complaints related to nucleic acid testing and document findings.
• Review, update, and create SOPs to standardize investigations.
• Identify reportable events and coordinate Product Quality Committee actions.
• Lead cross-functional teams to implement quality improvements and monitor results.
• Mentor junior staff and support training; back up supervisor/manager when needed.

Skills

Nonconformance handling

CAPA management

Regulatory audits

Nucleic acid testing

Education

BA/BS in biology or related

Tools

SAP

Salesforce

Excel

PowerPoint

Job description

Grifols is seeking a Senior Quality Assurance Specialist in San Diego to manage nonconformances, CAPA records, and audits. The role drives quality improvements through data analysis, cross-functional collaboration, and risk assessments.

Responsibilities include leading quality meetings, reviewing manufacturing documents, mentoring staff, and coordinating regional QA activities. A BA/BS in a related field with 5–8 years of experience is preferred, with ASQ certification a plus.