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Analytical Validation Specialist III

Portsmouth, NH 03801

Posted: 03/03/2025 Employment Type: Contract Job Category: Other Job Number: 617866 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 70-83.09/hr **salary will be commensurate with experience 

Job Description: 

The Analytical Validation Specialist III role will assist validation activities including, but not limited to, software updates, new system introduction, and decommissioning of analytical systems. The individual will work closely with Senior Analytical Validation Specialists and other functional groups to contribute to quality, and right first time performance. This role requires closer support from other Subject Matter Experts and Management.

•    Develop Technical Knowledge and documentation on analytical equipment.

•    Provide Subject Matter Expert support for troubleshooting of analytical equipment.  
 
•    Assist and support the planning and execution of validation plans involving analytical equipment changes.

•    Perform advanced troubleshooting and advanced helpdesk tickets (template creations, focus control etc.)

•    Execution of Installation Qualifications/Operational Qualifications and Performance Qualifications.

•    Own change requests and complete change request tasks to support project completion

•    Assist in Generating User Requirements Specification Documentation, complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.

•    Review analytical equipment, manuals, and help devise validation plans

•    Identify Quality Issues, involve stakeholders, help drive to completion/resolution

•    Assist in completion of Correct Actions/Preventative Actions

•    Review/Approve Commissioning Qualification Validation Documents

•    System Acceptance Ownership and Completion

•    Vendor escorting as needed

•    Demonstrates ownership and remediation of Data Integrity

Skills:

• Good working knowledge on Validation deliverables and Data Integrity principles.
• 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.  
• 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 


Education:
High School Diploma or Equivalent; (4 year degree strongly preferred) 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Portsmouth, NH

Discover exciting job opportunities in the vibrant Portsmouth, New Hampshire area today! Located on the beautiful Seacoast, Portsmouth boasts a rich history, picturesque landscapes, and a thriving arts scene. Home to iconic landmarks like the historic Strawbery Banke Museum and Prescott Park, this charming coastal city offers a unique blend of culture and opportunity for career growth. With its renowned local cuisine, diverse art galleries, live theaters, and outdoor recreation at places like Great Bay National Wildlife Refuge, Portsmouth is an enticing place for job seekers to build their careers. Explore our job listings in this enchanting region and take the next step towards a fulfilling career in Portsmouth!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.