Kelly Science, Engineering, Technology & Telecom · 2 hours ago
QA Validation Specialist (Contract)
Irvine, CA
Contract
Onsite
Senior Level
$38/hr - $40/hr
5+ years expKelly Science, Engineering, Technology & Telecom is seeking a skilled QA Validation Specialist (Contract) to join a leading pharmaceutical team supporting critical cGMP qualification and validation activities. This role involves hands-on ownership of equipment, facility, and laboratory validations, ideal for experienced validation professionals who excel in regulated environments.
Staffing & Recruiting
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
Other responsibilities and special projects will be assigned based on business and customer needs
Qualification
Required
Bachelor's degree in Sciences
5+ year's of experience in a highly regulated pharmaceuticals industry or related field
Demonstrated experience with qualification of commercial processing a 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
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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