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Clark & Enersen · 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

Clark & Enersen is a leading global consulting firm in life sciences, seeking an experienced consultant for quality control instrumentation validation and analytical method lifecycle activities. The role involves hands-on work with analytical instrumentation and ensuring compliance with global regulatory expectations.

Consulting

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/execute appropriate PQ protocols

Author PQ final reports including trace matrices and data integrity assessments

Qualification

KNEAT experienceMethod developmentMethod validationHPLC methodsManufacturing PracticesAnalytical instrumentation experienceLaboratory 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