Associate QA Validation Specialist

About the Role

The Associate QA Validation Specialist validates and qualifies equipment, systems, and processes in accordance with regulatory requirements and supports, follows, and implements company manufacturing standards, policies, and procedures. This position is for the cleaning Validation team.

Responsibilities

• Generates, implements, 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 that occur and determines solutions or recommendations for changes and/or improvements.
• Reviews, edits, and approves deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports, and other documentation.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• May supervise, provide direction, and assign work to Validation Specialists and/or contingent workers to meet goals and deadlines.
• Manages projects and prepares status reports.
• May present at both internal and external (regulatory) audits.
• Other duties assigned by management.

Some travel may be required.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences.
• 0-2 years of relevant experience for an Associate.
• 2+ years of relevant experience for a Specialist.
• 5+ years of relevant experience for a Senior Specialist.
• 8+ years of relevant experience for a Principal Specialist.
• May substitute proven experience for education requirement.

Skills

• 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 drives to improve processes for improved performance.
• Demonstrates supportive behavior at all times.
• Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint).
• Gathers and organizes information.
• Meets commitments on time.
• Performs well-defined tasks.
• Effective time management skills.
• Seeks to identify continuous improvement needs.

Pay

Salary Range (annually) $62,355.00 - $92,400.00