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ELIQUENT Life Sciences · 2 months ago

QC Test Method Validation Engineer

Thousand Oaks, CA, US

Full-time, Part-time

Onsite

Senior Level

$55/hr - $65/hr

5+ years exp

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies. They are seeking an experienced consultant to lead quality control instrumentation validation and analytical method lifecycle activities within a regulated life sciences environment, ensuring compliance with global regulatory expectations.

ConsultingMedical DeviceProfessional Services

H1B Sponsor Likely

Responsibilities

KNEAT experience (electronic validation system)

Develop and execute test method transfers/validation/verification protocols for QC Methods. Examples include:

HPLC methods

Osmolality assay

SDS Page assay

Develop method SOPs for multiple materials

Demonstrated method troubleshooting capability

Validation of quality control instruments (spectrometers) including the following:

Review and update User Requirements Specifications (URS) and generate system design and configuration specifications

Review and update instrument operations and maintenance Standard Operating Procedures (SOPs)

Manage/support vendor instrument IOQ process and develop/executeappropriate PQprotocols

Author PQ final reports including trace matrices and data integrity assessments

Qualification

KNEAT experienceMethod developmentMethod validationAnalytical instrumentationICH Q2 requirementsManufacturing PracticesLaboratory safety knowledgeCommunication skills

Required

Bachelor's Degree or superior

Method development and method validation

5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field

Strong understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices

Strong experience with ICH Q2 method qualification/validation requirements, USP, EP, and JP Pharmacopeia

Knowledge of Good Manufacturing Practices (also cGMP) compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniques

Strong verbal and written communication skills

Preferred

Hands-on analytical instrumentation experience

Benefits

Health, dental, vision, and life insurance

401(k) plan with employer match

Generous paid time off policy

Additional perks

Company

ELIQUENT Life Sciences

ELIQUENT Life Sciences is a regulatory consulting firm for the life sciences industry.

Washington, District of Columbia, USA

501-1000 employees

https://eliquent.com

H1B Sponsorship

ELIQUENT Life Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2025 (29)

2024 (3)