USA - Scientist#26-24247

$58.39-$62.16 per hour

Newbury Park (Thousand Oaks), CA

Onsite Job Description

Actual Job Title:

Quality Control Analytical Scientist II

100% ONSITE

Dept/Location Analytical Quality Control (AQC) - Thousand Oaks

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. Physical Demand The overall physical exertion of this position requires light to medium work.

Working

Environment Normal office and laboratory environment.

May need to work in controlled or clean room environments requiring special gowning.

May work around chemicals such as alcohol, acids, and buffers that may require

respiratory protection.

Able to work more than 8 hours a day or 40 hours a work week as needed.

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."