Job Details

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a QA Specialist III/IV (auditing) to work for an Orange County area contract development and manufacturing company.

Temp-to-perm: 6+ months

Summary

Our client is seeking a QA Specialist III/IV (auditing) to serve as the senior technical quality leader for the contract testing laboratory. They will also act as the primary quality representative during client audits, regulatory inspections, and major quality investigations.

Responsibilities

Quality Leadership

• Provide technical leadership for all quality systems.
• Drive inspection readiness activities.
• Assess compliance risks and recommend mitigation actions.

Client Audit Program

• Primary host for:
• Lead:
• Daily audit discussions
• Audit response preparation

Regulatory Inspection Readiness

• Coordinate FDA inspection readiness activities.
• Lead laboratory inspection mock audits.
• Track remediation activities.
• Maintain inspection readiness metrics.

Advanced Investigation Oversight

• Lead review of complex:
• OOS investigations
• OOT investigations
• Data integrity issues
• Method-related deviations
• Evaluate root cause analysis and CAPA effectiveness.

Computerized Systems and Data Integrity

• Provide QA oversight for:
• LIMS
• Chromatography data systems
• Electronic records
• Audit trail review programs
• Support validation and periodic review activities.

QA Staff Support

• Lead entry level QA Specialists.
• Provide GMP and audit-hosting training.
• Support onboarding of laboratory employees
• Manage supplier management activities such as quality agreements, re/qualifications

Internal Audit

• Manage internal audit program including standardization of activities

Experience/Requirements

• 5+ years of GMP laboratory quality experience with master's degree in Biosciences or Regulatory, or 8+ years GMP laboratory quality experience with a bachelor's degree in a scientific or regulatory related discipline.
• Demonstrated experience hosting client audits.
• Strong knowledge of 21 CFR Part 211, FDA Data Integrity Guidance, USP General Chapters, Laboratory computerized systems, OOS Guidance, and Analytical method lifecycle concepts
• Advance experience and knowledge of cGMP regulations, and FDA and ICH guidelines