Senior Validation QA Analyst

PSC Biotech® Corporation; Pomona (CA); On-site; USD 110,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental, and Vision premiums

401(k) and matching

PTO and Paid Holidays

Education Assistance

Pet Insurance

Discounted Anytime Fitness

Financial Perks and Discounts

Job summary

PSC Biotech® Corporation in Pomona, CA is seeking a Quality Engineer to provide QA oversight of validation documentation, ensure GMP compliance, and maintain inspection-ready records. The role focuses on review, approval, and management of validation deliverables within a regulated pharmaceutical environment.

Ideal candidate has 5+ years in QA/validation, strong documentation controls, and experience with IQ/OQ/PQ, risk assessments, and change control.

Qualifications

• Minimum 5 years of QA, Validation, or Validation Document Review within a GMP environment.
• Experience reviewing and approving validation documentation.
• Strong knowledge of IQ/OQ/PQ, risk assessments, and change controls.

Responsibilities

• Perform QA review and approval of validation documentation.
• Ensure validation documents comply with internal procedures, GMP requirements, and regulatory expectations.
• Review validation documentation for accuracy, completeness, traceability, and technical adequacy.
• Identify documentation deficiencies and collaborate with Validation, Engineering, Manufacturing, and Quality teams to resolve issues.
• Provide QA guidance regarding documentation requirements and quality compliance expectations.
• Review and approve quality system records associated with validation activities, including deviations, investigations, CAPAs, and change controls.
• Verify that validation deliverables are properly documented, approved, and maintained per document control requirements.
• Support audit and inspection readiness by ensuring Validation records are complete and accessible.
• Participate in internal audits and regulatory inspections as needed.
• Assist with continuous improvement initiatives related to validation documentation and quality systems.

Skills

Quality Assurance

Validation

Documentation Review

GMP Compliance

Communication Skills

Independent Work

Education

Bachelor's degree in Engineering/Life Sciences/QA or related field

Tools

Document Management Systems

CAPA

Deviation Management

Job description

PSC Biotech® Corporation in Pomona, CA is seeking a Quality Engineer to provide QA oversight of validation documentation, ensure GMP compliance, and maintain inspection-ready records. The role focuses on review, approval, and management of validation deliverables within a regulated pharmaceutical environment.

Ideal candidate has 5+ years in QA/validation, strong documentation controls, and experience with IQ/OQ/PQ, risk assessments, and change control.