Quality Assurance Validation Specalist

Kelly® Science & Clinical is seeking a Quality Assurance Validation Specialist for a contract position at a premier pharmaceutical client in Irvine, CA If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Empowering Experts.

• Job Title:

• QA Validation Specialist (Contract)

• Duration:

• 10 months

• Location:

• Irvine, CA (onsite)

• Rate:

• $40-43/hr. This position involves 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. + Other responsibilities and special projects will be assigned based on business and customer needs.

• QUALIFICATIONS

• + Bachelor's degree in Sciences + 5+ year's of experience in a highly regulated pharmaceuticals industry or related field + 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. + 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.

• What happens next:
• Once you apply, you'll proceed to next steps if your skills and experience look like a good fit.

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