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Sr. QC Method Development & Validation Analyst

BioPhase Solutions
Los Angeles, CA
  • Posted: over a month ago
  • Full-Time
Job Description
BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Sr. QC Method Development and Validation Analyst to work for a Greater Los Angeles area nutrition company.

Summary:
This position will serve as a senior level Subject Matter Expert (SME), technical resource and contributor in one or more specialized functions. They are required to lead and support the development, validation, and implementation of methods used for testing of incoming raw materials, raw milk, in-process, final product, stability, environmental monitoring, and facility/utility sampling. Additionally, they are required to 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.

Responsibilities:
  • Experience with anaerobic and aerobic microbiology techniques and phenotypic characterization of diverse microbes
  • Deep expertise in microbial and molecular biology testing methods, including cell culture and identification by qPCR
  • In-depth understanding and adherence to the Quality System requirements established by the company
  • Knowledgeable in all conventional aspects of field
  • Demonstrates full understanding of routine laboratory procedures
  • Demonstrates expert knowledge of project/process flow within discipline
  • Applies extensive technical expertise and has knowledge of other related business disciplines/processes
  • Independently evaluates, selects and applies standard techniques and procedures
  • Supports the development/optimization of new and existing methods required for the testing of raw materials, raw milk, in-process, and final product samples
  • Preparation of experimental design, analytical method development, and analytical method validation protocols and reports
  • Explores new methodology for improvements
  • Provides subject matter expertise and leadership for the investigation and evaluation of non-conformances related to laboratory testing (OOSs, NCs, LIRs, ORs, CAs and/or CAPAs)and other investigations as necessary
  • Provide subject matter expertise for the evaluation and conclusion of laboratory investigations
  • Utilizes significant knowledge of raw materials and finished goods testing in preparing conclusions and recommendations
  • Frequent 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
  • May make minor adaptations and modifications
  • Support the development and execution of validation studies and research projects
  • Works on complex projects requiring evaluation of materials testing
  • Participating in self-inspections and regulatory inspections
  • Provide data analysis and trending
  • Provides technical solutions to a wide range of difficult problems
  • On-going continuous improvement projects
  • Ability to enter and manage data within a LIMS system
  • Write and/or revise Standard Operating Procedures (SOPs)
  • Write and/or review test specifications
  • Provides leadership, guidance, and training to junior colleagues on a regular basis
Qualifications:
  • Bachelor’s degree in Microbiology, Molecular biology and Biotechnology, Biochemistry or related discipline; MS/PhD in technical field highly desired
    • 6+ years with Bachelors, 3+ years with Masters, 0+ years with PhD
      • with hands-on experience in quality control, 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)

Please send resumes to tiffany@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!

BioPhase Solutions

Address

Los Angeles, CA
USA

Industry

Technology

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