Validation Senior Analyst
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Job Location:
Norfolk, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Summary:
Responsible for ensuring that equipment process and analytical methods are validated. Support production by providing ongoing quality engineering support throughout the product life cycle and perform Non Conformance (NC) and Out Of Specification (OOS) investigations. Principal Duties and Responsibilities: Review and execute Installation (IQ) Operation (OQ) and Performance Qualification (PQ) test method validation protocols (TMV) and analytical test methods. Provide guidance/direction to teams upon review of validation documentation. Serve as a hands-on Validation Lead for Validation of changes to existing processes systems and equipment. Review equipment manuals specifications drawings and operational documents to ensure validation and qualification protocols and standard operating procedures are in-line with manufacturers specifications operational procedures calibration requirements and required maintenance. Perform Non Conformance (NC) and Out Of Specification (OOS) investigations. Analyze processes and methods related to quality improvement (e.g. Six Sigma statistical tools etc.) product and process risk management (PFMEA) and corrective and preventive action (CAPA). Assist with audits explaining validation and qualification activities performed at the site. This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
| Skills: | Expected Areas of Competence (i.e. knowledge skills and abilities) Proven ability to write technical documentation Proven ability to write analytical methods requirements and tests Able to lead and prioritize tasks and to drive projects to completion Ability to communicate in a clear concise manner including previous experience in writing technical documentation Able to work in a team environment Possess strong organizational and interpersonal skills |
| Education: | Education/Experience Requirements Bachelor of Science Degree in relevant field (science engineering etc.) 5-7 years related experience or equivalent combination of education and experience |
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
