Validation Senior Analyst
S3 Staffing USA
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Job Details
Skills
- Auditing
- Corrective And Preventive Action
- FMEA
- IQ
- OQ
- PQ
- Quality Assurance
- Quality Improvement
- Risk Management
- Six Sigma
- Test Methods
- Writing
- Standard Operating Procedure
- CAPA
- PFMEA
- OOS
- NC
- TVM
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.
- 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 manufacturer’s 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.
- 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/Experience Requirements
- Bachelor of Science Degree in relevant field (science, engineering, etc.)
- 5-7 years related experience or equivalent combination of education and experience
- Dice Id: 91159673
- Position Id: 8887817
- Posted 15 days ago
Company Info
About S3 Staffing USA
S3staffingusa is an industry-leading consultant firm specialising in IT-based staffing and software development solutions. We serve as an effective teammate for our international partners to help meet the business objectives set by end customers. Over the past few years, we’ve maintained a steadily growing presence in the industry, and can currently boast of a 200+ strong resource organisation to supervise our customers’ critical operations and intricate business applications.
Our firm is based on the philosophy of cultivating long-term relationships with clients, which is achieved by mastering development of cutting-edge technologies and incorporating proven process-driven methodologies into our workflow. Such competitive advantages are the secret behind how we provide effective, timely technology solutions to our clients, while strictly adhering to budget limits and being involved in a collaborative approach with them. If technology-based solutions to tackle a dynamic and demanding business environment are necessary, then look no further than S3staffingusa.
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