QC Senior Validation Analyst-Methods Validation
Position Type :
Experience Level :
Start Date / End Date :
02/18/2013 / 08/18/2013
Job Title: QC Senior Validation Analyst-Methods Validation
Job Category: Clinical and Scientific
Responsible for developing and validating release, in-process and cleaning methods in support of Client Diagnostic’s immunodiagnostic products. This role will interact with Technology Development, Manufacturing, Research & Development, Quality Control and Quality Assurance staff to ensure that method validation and transfer studies are appropriate for the methods’ intended use(s) and comply with applicable regulatory and company validation requirements.
Assist with development and validation of analytical test methods for immunodiagnostic products and intermediates in accordance with ICH/USP requirements and Client Quality Module guidelines
Write analytical method validation protocols, method validation summary reports, and method development reports
Execute validation protocols and train and provide technical assistance to fellow QC Methods Validation and QC Chemistry team members
Review method development and validation data to ensure completeness and accuracy
Evaluate existing analytical method validation packages for accuracy and compliance with current ICH and Client Quality Module guidelines
Perform deviation investigations and CAPA implementation in support of method validation projects
Assigned tasks may require standing for up to 7 hours a day, handling chemicals and potentially infectious reagents including HIV and HCV positive serum or plasma samples. May require lifting or moving materials and test equipment during the performance of assigned tasks.
Timely execution of approved method validation protocols according to established plan.
Timely completion of written method validation protocols and reports.
A minimum of 5 years in a GMP analytical testing environment (Pharmaceutical or Diagnostics/Device industries)
Experience/Professional Requirements: A minimum of 5 years in a GMP analytical testing environment (Pharmaceutical or Diagnostics/Device industries)
· Experience in executing analytical test protocols
· Experienced in protein chemistry and immunochemistry methods such as SDS-PAGE, ELISA, reversed phase and size exclusion chromatography, absorbance assays, and Western Blots desirable
· Excellent written and communication skills, scientific report writing
· Proficiency in MS Word and Excel. Proficiency in other statistical analysis software desired.
Job title will be dependent on the level of education, as well as technical depth and breadth.
Bachelors degree in Chemistry, Biology, or a related field,
Hrs per Wk: 40.00
Hrs per Dy: 8.00
A10 - 10 months ago