Job code : -6861-2-11 / 17
Hi All,
Urgent need in Thousand Oaks for a QC Test Method Development Engineer.
QC Test Method Development Engineer
Term- 6 months+
Onsite in Thousand Oaks, CA
HPLC is a must and candidates will be asked about the types.
We are seeking an experienced consultant to lead the quality control (QC) instrumentation validation and analytical method lifecycle activities within a regulated life sciences environment. This role involves hands-on work with analytical instrumentation, method validation, and data integrity to ensure compliance with global regulatory expectations.
Essential Duties and Responsibilities :
- KNEAT experience (electronic validation system)
- Develop and execute test method transfers / validation / verification protocols for QC Methods. Examples include :
HPLC methods
Osmolality assaySDS Page assayDevelop method SOPs for multiple materialsDemonstrated method troubleshooting capabilityValidation 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 protocolsAuthor PQ final reports including trace matrices and data integrity assessmentsRequirements :
Bachelor's Degree or superiorMethod development and method validation5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS / BA Degree in Science / related fieldStrong understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practicesStrong experience with ICH Q2 method qualification / validation requirements, USP, EP, and JP PharmacopeiaHands-on analytical instrumentation experience is preferredKnowledge of Good Manufacturing Practices (also cGMP) compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniquesStrong verbal and written communication skills