Document Specialist

  • location: Rockville, MD
  • type: Contract
  • salary: $29.56 - $34.78 per hour

description

Chat with me now! - https://flashrecruit.com/jobs/293315

Job Title: Validation Engineer

Job Summary

  • The primary responsibility is to support Data Integrity (DI) activities associated with computerized laboratory instruments.
  • These include data integrity assessments, identification of corrective actions and remediation of gaps for analytical instruments across GMS Rockville manufacturing and laboratory areas.

Job Responsibilities

  • Support completion of standardized system assessment tool with key stakeholders for all analytical instruments.
  • Develop CAPA plan and perform, as directed, corrective actions to address DI findings.
  • Author and/or revise analytical instrument User Requirements Specifications to align with DI and GSK standards.
  • Authors final reports summarizing execution of analytical instrument qualification protocols.
  • Authors support documents (amendments, repeat test forms, addenda and deviations) in support of analytical instrument qualifications.
  • Ensuring compliance with and completion of deliverables as specified within the Data Integrity Plan.
  • Ensuring analytical instruments are maintained in a qualified state.
  • Supporting the GMS Rockville analytical instrument validation program to assure compliance with GQMS and AEQMS.
  • The job holder will have the responsibility of supporting the implementation and mitigation of gaps associated with the Data Integrity Plan.
  • The job holder will work closely with System Owner, Manufacturing, QA, QC, IT and Validation groups.
  • The job holder will have familiarity with laboratory environments, analytical instruments and computerized systems.

Education & Qualifications

  • Has a degree in an appropriate science (chemistry, biology, biochemistry, etc.) based discipline.
  • Demonstrate competence through significant experience in their degreed discipline.
  • Familiarity with the operation of analytical instruments and their operating systems.
  • Familiarity with computerized system validation and data integrity.
  • Experience of working with cross-functional teams of diverse people.
  • Strong interpersonal / communication (verbal and written) / presentation skills.
  • Ability to work as part of a team and to be accountable.
  • Knowledge of cGMPs.
  • High level of IT literacy and experience with IT applications (MS Office suite, eDocCompliance, LIMS, etc.).
  • Demonstrable planning, organizing and problem solving skills.
  • Demonstrates decision making in time constrained and complex situations.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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