What are the responsibilities and job description for the Analytical Validation Specialist position at Tailored Management?
Job Title : Analytical Validation Specialist
Location : 101 International Drive, Portsmouth, NH 03801
Job Type : 9-Month Contract with Possibility of Extension or Full-Time Conversion
Payrate : $83.04 per hour on W2
Department : Quality Control
Reports to : Associate Director, QC
Job Description :
The Analytical Validation Specialist will lead and support validation activities including software updates, new system introductions, and decommissioning of analytical systems. This role collaborates with Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to ensure compliance, timely project delivery, and right-first-time performance. The specialist will be responsible for validation planning, execution, documentation, and troubleshooting while ensuring adherence to cGMP standards and data integrity principles.
Key Responsibilities :
- Serve as Subject Matter Expert (SME) for the design, operation, and troubleshooting of analytical equipment.
- Develop, plan, and execute validation protocols (IQ / OQ / PQ) for analytical equipment and systems.
- Manage TrackWise records including Change Controls, CAPAs, and Deviations.
- Generate and review User Requirements Specifications, Data Integrity Risk Assessments, and Audit Trail Risk Assessments.
- Oversee procurement, budgeting, and installation of analytical equipment.
- Collaborate with cross-functional teams to identify and resolve quality issues.
- Conduct risk assessments and approve commissioning, qualification, and validation documents.
- Provide vendor management and escorting during equipment commissioning.
- Demonstrate ownership of Data Integrity remediation and continuous improvement.
- Assist with technical documentation, advanced troubleshooting, and project support as needed.
- Promote and maintain a safe working environment by adhering to cGMP and company safety policies.
- Education and Experience :
- Bachelor's degree in a science-related field required.
- 3-8 years of experience in Manufacturing, Quality Control, or Validation within the pharmaceutical / biotech industry.
- Experience with Quality Systems (TrackWise), deviations, change controls, and CAPAs.
- Proficiency in process, equipment, cleaning, and computer system validations.
Skills and Competencies :
Work Environment :
Application Process :
Salary : $83
