Quality Control Validation Scientist

Published: 6/14/2022

Manufacturing

We are hiring Quality Control Validation Scientist.

Please let me know if you are interested or anyone who might be interested.

Client: Major Pharmaceutical Client

Position: Quality Control Validation Scientist

Duration: 12+ Months Contract

Location: Newbury Park (Thousand Oaks), CA 91320

Pay Rate: $60.00-$64.00/ Hr on W2

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Description:

As a QC Analytical Scientist, you will support Quality Control activities within the Analytical Quality Control (AQC) department.
Key responsibilities include transferring and executing analytical methods for raw materials and finished products in a cGMP environment, across both Analytical QC (AQC) and QC Microbiology (QCM).

Essential Duties and Responsibilities:

Drive analytical method validation and transfer of laboratory methodologies
Support execution, issue resolution (e.g., discrepancies), and approval of test plans/protocols
Troubleshoot analytical methods as needed
Ensure laboratory equipment is maintained in a validated state and that all methods meet regulatory and internal requirements
Prepare protocols, reports, and other technical documentation, including support for raw material qualification
Apply scientific principles and statistical techniques to solve problems and provide recommendations
Support installation, operational qualification (IOQ), maintenance, and troubleshooting of laboratory instrumentation
Ensure deliverables meet defined timelines and milestones
Perform other duties as assigned

Qualifications:

Strong technical writing skills with the ability to generate compliant documentation and reports
Knowledge of analytical methods and laboratory operations with strong problem-solving skills
Understanding of analytical method validation
Intermediate statistical knowledge with experience in data analysis
Knowledge of cGMP and laboratory-related requirements such as method validation and investigation of unexpected results
Basic understanding of regulatory requirements related to analytical instrumentation and test methods
Working knowledge of regulatory standards such as cGMP, QSR, USP, 21 CFR, and ICH
Ability to work independently with minimal supervision and demonstrate basic project management skills
Ability to multitask in a fast-paced environment
Strong attention to detail, organization, and time management skills
Proficiency in Microsoft Office
Business-oriented and strategic thinking

Education and/or Experience:

Bachelor’s degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or a related field
Minimum 1 year of experience in analytical development or validation in a pharmaceutical, biopharmaceutical, or related environment, or an advanced degree

Physical Demand:

Working Environment:

Office and laboratory environment
May work in controlled or cleanroom environments requiring special gowning
May handle chemicals such as alcohols, acids, and buffers, requiring appropriate safety measures
Ability to work extended hours as needed

Regards

Vishnu Das Natesan