QA Specialist III/IV

BioPhase Inc.; Irvine (CA); Presencial; USD 110.000 - 170.000; Jornada completa

Descripción de la vacante

BioPhase Solutions is seeking a QA Specialist III/IV (auditing) to act as the senior quality leader for a contract development and manufacturing lab in Orange County. You will host client audits, drive inspection readiness, and lead investigations across LIMS and chromatography systems, ensuring data integrity and CAPA effectiveness.

The role requires 5+ years of GMP quality experience with an advanced degree or 8+ years with a bachelor’s in a related field; familiarity with 21 CFR Part 211, FDA

Formación

• 5+ years of GMP laboratory quality experience with a master’s degree in Biosciences or Regulatory, or 8+ years with a bachelor’s degree.
• Demonstrated experience hosting client audits and regulatory inspections.
• Strong knowledge of 21 CFR Part 211, FDA Data Integrity, USP General Chapters, and cGMP guidelines.

Responsabilidades

• Provide technical leadership for all quality systems and drive inspection readiness.
• Serve as primary QA host during client audits and regulatory inspections.
• Lead complex investigations (OOS, OOT, data integrity issues) and CAPA effectiveness reviews.
• Oversee computerized systems like LIMS and chromatography data systems, and support validation.
• Supervise QA staff and support onboarding of laboratory personnel; manage supplier quality activities.
• Coordinate internal audits and standardize audit activities.

Conocimientos

Quality leadership

Audit hosting

Regulatory knowledge

Data integrity

CAPA & investigations

GMP experience

Educación

Master’s degree in Biosciences or Regulatory

Bachelor’s degree in scientific/regulatory discipline

Herramientas

LIMS

Chromatography data systems

Electronic records

Audit trail review programs

Descripción del empleo

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