Quality Assurance Validation Associate

Scorpion Therapeutics; Thousand Oaks (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Scorpion Therapeutics seeks a Quality Assurance Validation Associate to lead oversight of validation deliverables, ensuring compliance with regulatory standards and internal SOPs. You will review and approve validation documents across facilities, utilities, equipment, process qualification, cleaning, QC methods, and computer system validation.

The role requires a Bachelor's in a related field and at least 5 years in pharmaceutical/biotech validation, with hands-on experience using Veeva and

Qualifications

• Bachelor's degree in biotechnology, microbiology, pharmacy, or related field.
• Minimum 5 years of experience in pharmaceutical/biotech validation.
• Proficiency with validation protocols and electronic document systems (Veeva, Kneat).
• Deep knowledge of GMP/EU regulations and GxP guidelines.

Responsibilities

• Evaluating validation master plans, qualification protocols, and change controls.
• Supporting validation for manufacturing systems and addressing risk assessments.
• Participating in audits.

Skills

GxP awareness

Auditing

Risk assessment

Documentation

Education

Bachelor's degree in Biotechnology, Microbiology, Pharmacy, or related field

Tools

Veeva

Kneat

Electronic document systems

Job description

Role:

Quality Assurance Validation Associate responsible for reviewing and approving validation deliverables to ensure compliance with regulatory requirements, internal standards, and industry best practices.

Main objectives:

Main objectives include providing quality oversight for validation documents related to facilities, utilities, equipment, process qualification, cleaning, QC methods, and computer system validation.

Core responsibilities:

• evaluating validation master plans, qualification protocols, and change controls
• supporting validation for manufacturing systems and addressing risk assessments
• and participating in audits

Requirements:

• Bachelor’s in Biotechnology, Microbiology, Pharmacy, or related field
• minimum 5 years of experience in pharmaceutical/biotech validation
• proficiency with validation protocols, electronic document systems (e.g., Veeva, Kneat)
• deep knowledge of GMP/EU regulations and GxP guidelines

Preferred qualifications:

Preferred qualifications include extensive cross-functional team experience and advanced certifications.

High-value specifics:

• biopharma manufacturing environment
• validation of facilities and systems
• GxP compliance
• involvement in regulated environments
• experience supporting manufacturing validation projects

Location/Work Setup:

based in Thousand Oaks, CA, with potential for in-person work in controlled environments. The role may involve working in gowning areas and around chemicals, requiring adherence to safety protocols.