Senior Qualification & Validation Specialist

RXinsider LTD.; Northern (KY); Hybrid; USD 65,000 - 89,000; Full time

Benefits offered by this job

Health and wellness benefits

401k retirement program with company 


Paid time off

Job summary

QuVa is seeking a Qualification and Validation Senior Specialist to drive compliance across all sites, overseeing qualification and validation plans, protocols, and testing. The role includes leading cross-site projects, supporting regulatory inspections, and ensuring cGMP adherence.

Responsibilities include authoring and reviewing IQ/OQ/PQ, writing SOPs and deviations, and providing training on qualification concepts. A Bachelor’s degree and 5+ years in validation are required.

Qualifications

• Associate’s/Bachelor’s degree or equivalent validation experience.
• 5 years’ Qualification and Validation experience including writing and executing protocols and commissioning documents.
• 5 years of pharmaceutical experience including knowledge of cGMP, GDP, FDA Aseptic Guidelines, ISO-14644, and other pharmaceutical regulatory requirements.
• Experience in performing smoke studies.

Responsibilities

• Provide evaluation, input, authoring, and review of qualification and validation master plans and protocols.
• Guide equipment, facilities, and utilities qualification through protocols and action plans.
• Lead execution of qualification and validation protocols and related testing.
• Support site inspections with technical background on qualification/validation efforts.
• Create and review IQs, OQs, PQs, engineering studies, and summary reports.
• Write and resolve deviations during protocol execution.
• Lead higher-level projects across sites to ensure timely completion.

Skills

Strong communication

Team collaboration

Problem solving

Education

Bachelor's degree or equivalent validation experience

Tools

Microsoft Word

Microsoft Excel

Computer Software Validation (CSV)

Job description

QuVa is seeking a Qualification and Validation Senior Specialist to drive compliance across all sites, overseeing qualification and validation plans, protocols, and testing. The role includes leading cross-site projects, supporting regulatory inspections, and ensuring cGMP adherence.

Responsibilities include authoring and reviewing IQ/OQ/PQ, writing SOPs and deviations, and providing training on qualification concepts. A Bachelor’s degree and 5+ years in validation are required.