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:

• Light to medium physical activity

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