QA Validation Specialist

We are seeking 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.

• 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.

• Bachelor’s degree in Sciences
• 5+ years of experience in a highly regulated pharmaceutical 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.

Associate

Contract

Science, Consulting, and Quality Assurance

Pharmaceutical Manufacturing

• Medical insurance
• Vision insurance
• 401(k)