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Eliquent Life Sciences, Inc

Quality Assurance Validation Specialist

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What they do

A Validation Specialist tests and documents the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implements operating procedures. May create documentation to show that a manufacturing or production process has consistent results and meets quality standards.

$90,261 / year median in Ohio

+2% projected growth

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Job Description

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. For more information, please visit our website at eliquent.com. 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.

Benefits

  • Paid Time Off (PTO)
  • 401(k) Plans
  • Professional Development
  • Other Retirement and Savings