Quality Assurance Validation Specialist Job Columbus area,Ohio USA,Quality Assurance

QA Validation Specialist

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients' needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices.

We at Eliquent are looking for an experienced QA Validation Specialist to immediately join our consulting team onsite in Columbus, OH. The QA Validation Specialist will be responsible for:

On-site review of IQ/OQ/PQ protocols for the installation of new equipment and product lines

Reviewing and assessing validation impact for various activities

Participating in risk assessments to ensure compliance with GMP and validation requirements

Ensuring validated systems remain compliant through periodic reviews and lifecycle management.

Qualifications /

Experience:

3 to 7 years of experience in Quality Assurance, Validation, Quality Systems, or a related role within a regulated industry.
Experience supporting validation lifecycle activities, including qualification, protocol execution, reporting, and change management.
Working knowledge of cGMP, GxP, FDA, EMA, ISO, or other applicable regulatory requirements.
Experience authoring, reviewing, and executing validation documentation, including IQ/OQ/PQ protocols and reports.
Knowledge of process validation, equipment qualification, and/or cleaning validation.
Familiarity with change control, CAPA, deviation investigations, and risk assessments.
Strong technical writing and documentation skills.
Experience with electronic Quality Management Systems (eQMS), document management systems, and Microsoft Office Suite. Understanding of data integrity requirements and validation lifecycle principles.
Education:

Bachelor's degree in Engineering, Life Sciences, Biology, Chemistry, Quality Assurance, Computer Science, or a related technical field

What We Offer:

Competitive Compensation:
Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
Career Development:
Opportunities for professional growth and advancement within a supportive and innovative environment.
Work-Life Balance:
Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.