GMP QA Specialist - Supplier Audits & Compliance

Celgard; Fremont (CA); On-site; USD 95,000 - 110,000; Full time

Benefits offered by this job

Healthcare insurance

Dental insurance

Vision insurance

Life Insurance

Disability Insurance

401K matching

Paid time off

Holidays and sick leave

Job summary

Bionova Scientific LLC is seeking a QA Compliance professional to support GMP quality assurance, supplier qualification, and internal/external audits. The role emphasizes meticulous documentation, collaboration with suppliers, and improving quality systems.

Responsibilities include supplier assessments, change control, discrepancy handling, and preparing for regulatory inspections. Requires strong communication, 5+ years in GMP QA, and ERP/eQMS proficiency.

Qualifications

• Bachelor degree in a scientific field and GMP QA experience.
• Minimum 5 years’ GMP Quality Assurance and Quality Systems experience.
• Experience with ERP and eQMS systems is required.
• Strong data analysis and trend analysis capabilities.
• Excellent written and verbal communication to document findings.

Responsibilities

• Assess suppliers' quality systems, processes and capabilities to meet standards.
• Interface with suppliers/clients to obtain material and documentation.
• Negotiate and maintain quality agreements outlining specs and QA targets.
• Perform actions with Change Control, discrepancies and supplier investigations.
• Conduct regular on-site supplier audits to verify GMP compliance.
• Identify quality risks and implement mitigation strategies.
• Communicate with procurement and QA teams to drive improvements.
• Enforce QA policies to maintain product quality and compliance.
• Coordinate inspection readiness and assist client/regulatory audits.

Skills

GMP Quality Assurance

Quality Systems

Data analysis

Written and verbal communication

Regulatory knowledge

Education

Bachelor of Science degree

Tools

ERP systems

eQMS systems

Quality management software

Job description

Bionova Scientific LLC is seeking a QA Compliance professional to support GMP quality assurance, supplier qualification, and internal/external audits. The role emphasizes meticulous documentation, collaboration with suppliers, and improving quality systems.

Responsibilities include supplier assessments, change control, discrepancy handling, and preparing for regulatory inspections. Requires strong communication, 5+ years in GMP QA, and ERP/eQMS proficiency.