Quality Control Validation Scientist

Lenox Executive Search is seeking a Quality Control Validation Scientist for a ONE-YEAR CONTRACT role with one of our global pharmaceutical clients. This is a ONE-YEAR CONTRACT with the possibility of extension.

Responsibilities:

• Drive analytical method validation/ transfer of laboratory methodologies
• Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols
• Support troubleshooting of analytical methods
• Ensure 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 and other technical documents as required. This may include supporting raw material qualification for new products
• Use sound scientific principles and statistical techniques to solve problems and make recommendations.
• May Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.

Qualifications:

• Strong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements
• Knowledge of analytical methods and operations with strong emphasis in problem-solving.
• Knowledge about analytical method validation.
• Intermediate statistical knowledge and experience with data analysis
• Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.
• Basic knowledge about regulatory requirements concerning analytical instrumentation, and test methods
• Substantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc.
• Proficient in Microsoft Office.
• Strategically and business-oriented thinking

Education-Experience:

• Bachelor’s Degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.
• Minimum of 7 years of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
• Nice to have the KNEAT Program, not required
• Experienced in reviewing and approving Life Cycle Validation Documents including:Familiar with paperless validation software for life sciencesCommissioning, Installation, Operational and Performance Qualification protocols and reports for Equipment, Facilities & Utilities at Biopharmaceutical Manufacture plant.Computer System Validation protocols and reports, including SCADA, MES.QC/Micro Laboratory Instrument Qualification and method validation.

Job Types: Full-time, Contract

Pay: $60.00 - $70.00 per hour

Education:

• Bachelor's (Required)

Experience:

• analytical method validation/ transfer of lab methodologies : 7 years (Preferred)
• Technical writing: 5 years (Preferred)
• data analysis: 7 years (Preferred)

Work Location: In person

Salary : $60 - $70