×
Register Here to Apply for Jobs or Post Jobs. X

QA Validation Specialist

Job in Irvine, Orange County, California, 92713, USA
Listing for: Kelly Services
Contract position
Listed on 2026-01-09
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist, QA Specialist / Manager
Job Description & How to Apply Below

We are seeking to identify a skilled QA Validation Specialist (Contract) to join a leading pharmaceutical team supporting critical cGMP qualification and validation activities. This 6-month contract offers $38‑40/hr. and hands‑on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit‑ready execution.

Responsibilities
  • Assists in assuring facility, manufacturing, packaging, and laboratory equipment are qualified to the required cGMP standards.

  • Authors/approves and executes qualification protocols and reports.

  • Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory instruments in coordination with operations, Quality Control and maintenance.

  • Assists sourcing and procurement of facility equipment and laboratory instruments through completion of following tasks.

  • Qualification of vendors selected.

  • Input to the development of the URS/FRS/DDS.

  • Assists with the routine calibration and maintenance of the Validation Master Plan for the site.

  • May present qualification studies to regulatory and client auditors as required.

  • Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.

  • Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.

  • Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.

  • Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.

  • Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.

  • Initiates and investigates exception reports and non‑conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.

Qualifications
  • Bachelor’s degree in Sciences.

  • 5+ years of experience in a highly regulated pharmaceuticals industry or related field.

  • Demonstrated experience with qualification of commercial processing and packaging equipment.

  • Proven track record of managing projects from start to finish on time and on budget.

  • Strong working knowledge of cGMP and regulatory standards for validation.

  • Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.

Kelly Services is proud to be an Equal Employment Opportunity and affirmative‑action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws.

A conviction does not automatically bar individuals from employment.

#J-18808-Ljbffr
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
 
 
 
Search for further Jobs Here:
(Try combinations for better Results! Or enter less keywords for broader Results)
Location
Increase/decrease your Search Radius (miles)

Job Posting Language
Employment Category
Education (minimum level)
Filters
Education Level
Experience Level (years)
Posted in last:
Salary