Analytical Validation Specialist IV

SGS_JOB_1074

Industrial
 New Hampshire
Analytical Validation
Quality Control
Validation Plans
SOPs
GMP
Risk Assessments
Equipment Procurement
Cross-functional Collaboration

Contract - 09 months + (Possibilities of Extension)

The Analytical Validation Specialist IV will lead the validation activities, focusing on analytical equipment, software updates, new system introductions, and decommissioning. This role will collaborate with cross-functional teams to ensure compliance with GMP and quality standards. The Specialist will manage the validation process, equipment specifications, and risk assessments to maintain a compliant and efficient operational environment.

Job Responsibilities:

  • Provide Subject Matter Expert support to Manufacturing, Quality Control, and other departments for analytical equipment design, operation, and troubleshooting.
  • Lead validation plans for analytical equipment changes and process improvements.
  • Oversee Installation Qualifications/Operational Qualifications and draft Performance Qualifications as needed.
  • Manage the creation and review of project documentation, including CC, CAPA, and deviations.
  • Generate User Requirements Specifications, perform data integrity risk assessments, and manage audit trail evaluations.
  • Ensure proper procurement of analytical equipment, including budgeting, specifications, and installation.
  • Act as the owner of all related analytical equipment and troubleshoot quality issues.
  • Participate in and review risk assessments related to validation.
  • Approve commissioning qualification documents and related validation reports.

Skills:

  • Advanced technical knowledge in Quality Control and manufacturing operations.
  • Familiar with Quality Systems such as TrackWise, deviations, CAPA, and OTNs.
  • Experienced in process, equipment, cleaning, and computer system validations.
  • Demonstrated project management experience.
  • Strong planning, organizing, and decision-making skills.
  • Excellent communication (written and verbal) and ability to work cross-functionally.
  • Proficient in MS Project, Word, Excel, and PowerPoint.

Education/Experience:

  • Bachelor’s degree in a science-related discipline or equivalent experience.
  • 5-10 years of experience in manufacturing, QC, or validation in a regulated environment.
  • Ability to work independently with minimal supervision.
  • Knowledge of cGMP and safety procedures in the industry.
  • Strong problem-solving and decision-making abilities.

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