HR Lynx
Los Angeles County, California, US
May 27, 2021
Jun 28, 2021
Employment Type
Full time
Salary Type
QC Method Development and Validation Analyst will lead and support the development, validation, and implementation of methods used to test incoming raw materials, in-process, final product, stability, environmental monitoring, and facility/utility sampling with a strong background in microbiology. Additionally, this candidate will lead and support, OOSs (Out of Specification), NCs (Non-Conformance), LIRs (Laboratory Investigation Report), ORs (Observation Report), CAs (Corrective Action) and/or CAPAs (Corrective and Preventative Action), and contract laboratory investigations. This role is required to provide expertise across multiple disciplines within the laboratory and to provide method development, validation, and implementation support.

Primary Duties and Responsibilities

In-depth understanding and adherence to the Quality System requirements
Full understanding of routine laboratory procedures and project/process flow
Supports the development/optimization of new and existing methods required for the testing of raw materials and final product samples
Preparation of experimental design, analytical method development, and analytical method validation protocols and reports
Provides subject matter expertise and leadership for the investigation and evaluation of non-conformances related to laboratory testing and other investigations as necessary
Provide inter-organizational and outside customer contacts; represents the organization in providing solutions to difficult technical issues associated with specific projects

Support/lead various QC projects with the design, testing, and implementation phases
Operates, maintains, and troubleshoots advanced analysis equipment

Support the development and execution of validation studies and research projects
Works on complex projects requiring evaluation of materials testing

Ability to enter and manage data within a LIMS system
Write and/or revise Standard Operating Procedures (SOPs) and test specifications

Job Requirements and Qualifications

Bachelor's degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, or related discipline; MS/Ph.D. highly desired
Hands-on experience in manufacturing, operations, or pilot lab/scale-up operations; experience in pharmaceutical scale-up activities, pharmaceutical validations, or extensive laboratory experience in protein chemistry/microbiology high desired
Working knowledge of method validation according to ICH (International Conference of Harmonization)