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
dvishnu@radiants.com
