Validation Specialist IV - Portsmouth, NH

Job Description

Job DescriptionJob Title: Analytical Validation Specialist IV
Job Description:
Summary:

• Analytical Validation specialist IV will lead validation activities including, but not limited to, software updates, new system introduction, and decommissioning of analytical systems.
• This person will work closely with other functional groups like Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to support updates to help the site remain in compliance and contribute to quality, on-time delivery and right first time performance.

Key Accountabilities:

• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of analytical equipment.
• Drive/own the validation plans and execution of analytical equipment changes and process improvements.
• Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
• Own all forms of TW records including CC/CAPA/Deviations to support project completion.
• Generating User Requirements Specification Documentation, complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
• Review analytical equipment, manuals, and devise validation plans
• Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.
• Analytical Equipment Ownership
• Identify Quality Issues, involve stakeholders, drive to completion/resolution
• Participate on Risk Assessments
• Review/Approve Commissioning Qualification Validation Documents
• Perform other duties as assigned.

Manufacturing, QC, Validation : Advanced 5-10 Years

Skills:

• Advanced technical knowledge of Quality control and manufacturing operations.
• Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations
• Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
• Demonstrated ability to manage medium to large sized projects within required timeframes.
• Demonstrate ability for effective Planning, Organizing and Controlling competency
• Demonstrate sound decision making.
• Ability to work inter-departmentally and with customers.
• Demonstrates role model behaviors for GMP and Safety behaviors
• Strong written and verbal communication skills
• Ability to work in MS Project, Word, Excel, PowerPoint

Agility:

• Learns from experience, errors and setbacks
• Helps others learn from experience to develop themselves
• Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond
• Embraces new initiatives and drives successful implementation in his/her area
• Adapts thinking and behavior to support change
• Takes personal responsibility for promoting change in his/her area
• Understands how to effectively engage others in the change processes

Business Acumen:

• Understands and explains the corporate strategy to his/her peers and/or team
• Provides feedback to his/her managers on the content of the strategy and its implementation
• Sets and delivers on individual and team objectives that support the company strategy
• Uses knowledge of his/her business area and related areas to make correct and timely decisions
• Uses knowledge of his/her own business area and related areas to identify and develop operational/financial improvements

Collaboration:

• Works in partnership as an active member of his/her team and cross- functional working groups
• Generously shares information and knowledge with others across teams and functions
• Actively seeks out and shares different perspectives from a broad network and implements alternative approaches
• Champions and role models the values of diversity and inclusion through everyday interactions in groups or 1:1s

Customer Focus:

• Proactively seeks to understand internal/external customer and market needs
• Develops insights that can be used to enhance customer satisfaction or other metrics
• Identifies when company and customer interests may not align and seeks effective solutions to resolve or escalate
• Manages internal and external customer relations professionally and effectively
• Uses systematic approaches to ensure customer key metrics are tracked and analyzed for continuous improvement

Driving Results:

• Establishes and consistently delivers on KPIs and challenging goals for him/herself (and team)
• Proactively shares credit for successes
• Helps peers (and team) overcome performance obstacles and challenges
• Secures buy-in from key stakeholders
• Ensures delivery excellence for own goals and those of his/her team
• Regularly solicits, assesses and addresses feedback
• Appropriately prioritizes multiple demands and leads defined work to successful conclusion on time

Leadership:

• Supports others in taking responsibility for a safe and sustainable environment
• Takes personal accountability for outcomes resulting from choices and behaviors of self and team
• Seeks and provides feedback to their team to support professional development
• Takes personal accountability for defining and implementing his/her own development and supports
• others to do same
• Creates a positive work environment for his/her team and demonstrates high integrity
• Ensures clear and direct 2-way communication within his/her team and other organization