Quality Control Analyst
Provide Analytical method development and testing support for the QC area. The individual will be responsible for development and validation of analytical methods for cleaning validation and other assigned analytical tasks. Other project support will be on an as-needed basis. The successful candidate must be an independent performer with significant experience in a cGMP environment, and will work with minimal supervision.
* Develop and validate analytical methodologies especially TOC methods related to cleaning validation/verification of manufacturing equipment in the manufacturing process.
* Conduct TOC and other analytical testing in the QC laboratory.
* Support analytical activities related to computer system remediation's in the QC laboratories.
* Participate in the Technical transfer/Co-Validation of new test methods including the generation of Protocols, Reports, SOP's and other Technical documentation when necessary.
* Conduct peer reviews of laboratory data for accuracy and completeness.
* Support departmental management in the resolution of Assay investigations, Deviations and Aberrant data issues.
* Mentor laboratory personnel in methods related to cleaning validation/verification.
* HANDS ON YEARS OF EXPERIENCE IN METHOD DEVELOPMENT/ VALIDATION AND TESTING EXPERIENCE IN A CGMP ENVIRONMENT IN A PHARMACEUTICAL OR MEDICAL DEVICE REQUIRED.
* Key technical competencies and soft skills:
* Significant hands on experience with TOC instrumentation and methodologies.
* Must have the ability to communicate verbally and in written format effectively through multiple layers of the organization
* Excellent organizational and interpersonal skills