Assoc QA Validation Specialist
About The Position
This role is responsible for validating and qualifying equipment, systems, and processes in accordance with regulatory requirements. The specialist will support, follow, and implement company manufacturing standards, policies, and procedures. The position involves generating, executing, and reviewing master and completed qualification and validation protocols, summary reports, and associated data. It also includes analyzing test results, investigating and troubleshooting problems, and reviewing/editing/approving deviation notifications, change controls, SOPs, and other documentation. The role requires coordination with other departments and vendors, training less experienced specialists, managing projects, and potentially overseeing contingent workers.
Requirements
- Ability to maintain integrity and honesty at all times
- Ability to work independently or as part of a team
- Ability to communicate with transparency
- Continuously drive to improve processes for improved performance
- Demonstrate respectful behavior at all times
- Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
- Gathers and organizes information
- Meets commitments on time
- Follows directions; performs well-defined tasks
- Effective time management skills
- Seeks to identify continuous improvement needs
- BS/BA in Engineering, Chemistry, or Life Sciences with 0-2+ years of related experience within the field preferred; may substitute relevant experience for education.
Responsibilities
- Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
- Reviews, edits and approves change controls, SOPs, reports and other documentation
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Trains/advises less experienced Specialists.
- Manages projects and prepares status reports.
- May be required to oversee contingent workers.
- Other duties assigned by management.
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
