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Analytical Scientist

Astrix Technology • Thousand Oaks, CA • 9h ago

Science & Research

Thousand Oaks, California, US

Added - 27/08/2026

Pay Rate Low: 57.00 | Pay Rate High: 62.00

6 month contract

Pay: $57-62/hr

Summary

As a QC Analytical Scientist II, you will support various Quality Control activities within the

AQC department. Key responsibilities are to transfer and execute analytical methods,

including raw materials, for use in a CGMP environment in Quality control, both analytical

quality control methods (AQC) and Quality Control Microbiology methods (QCM).

Essential Duties and Responsibilities

·Drive special projects that require AQC attention/leadership.

·Drive analytical method development and validation of laboratory methodologies and

instrumentation. This includes leading analytical/microbiology QC efforts to support the

introduction of new product testing, modifying existing laboratory space, plan design

new laboratory spaces and working with vendors to purchase new instruments, and the

installation and qualification of new instruments.

·Support investigations and manufacturing investigations requiring analytical method

support.

·Support the installation, operational qualification (IOQ), maintenance and

troubleshooting of instrumentation in the AQC group.

·Serve on project teams, in a leadership role as needed, which will require substantial

interaction and communication with other group functions.

·Upgrading of analytical technologies within an established licensed technology platform.

·Support the execution and issue resolution (e.g., discrepancies) and completion approval

of test plans/protocols

·Support troubleshooting of analytical methods and instruments and support laboratory

investigations as needed to provide scientific justification for initial Out of Specification

(iOOS), Out of Trend (OOT), and atypical result investigations

·Review and approve laboratory investigations, deviations, CAPAs, and periodic reviews,

and other documentation that requires advanced analytical knowledge.

·Ensure all laboratory equipment is maintained in a validated state and that all analytical

methods transferred follow company and regulatory requirements.

·Responsible for protocol and report generation as well as authoring CMC submission and

other technical documents as required. This includes supporting raw material

qualification for new products

·Manage and perform assay control and critical reagent qualifications, including

monitoring and trending of method performance.

·Support the analysis of QC data using statistical tools to identify trends and set limits for

results, including data transcription/entry

·Use sound scientific principles and statistical techniques to solve problems and make

recommendations.

·Responsible for deliverables to ensure timelines and milestones are met.

·Support scheduling of AQC and QCM testing (release, execution of protocols, etc.).

·Lead small teams as needed to accomplish tasks.

·Representative for Analytical projects with global and local site functions. Ensure Right

First Time (RFT) in the method introduction and instrument qualification process

·Other duties as assigned.

Qualifications

·Excellent technical writing skills and able to write technical documents and reports that

meet company and regulatory requirements

·In depth knowledge of analytical methods and operations with strong emphasis in

problem-solving.

·Knowledge about analytical method validation and critical reagent qualification.

·Intermediate statistical knowledge and experience with data analysis.

·Knowledge concerning cGMP, especially lab related topics such as method validation and2

unexpected results investigation.

·Basic knowledge about regulatory requirements concerning analytical instrumentation,

test methods and licenses.

·Substantial knowledge and understanding in terms of regulatory standards requirements

e.g., CGMP, QSR, USP, 21CFR, ICH etc.

·Ability to complete tasks with minimal direction, demonstration of basic project

management skills.

·Ability to multi-task in a highly dynamic and diverse environment.

·Attention to detail, good organization, and time management skills to meet deadlines.

·Proficient in Microsoft Office.

·Strategic and business-oriented thinking.

Education and/or experience

·Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.

·Minimum of 3 years of analytical development or validation experience in GMP

Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an

advanced degree.

LI-ZW1

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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