Senior Specialist Packaging And Labeling (Contract)

• Track data for the purpose of metrics generation
• Archiving of batch documents in electronic document system
• Perform disposition activities for Finished Goods in support of Commercial Product, including:
  • Master and Executed Batch Record review and resolution of comments/issues
  • Archiving of batch documents in electronic document system
  • Track data for the purpose of metrics generation
  • Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status
  • Disposition Decision and status change in Oracle
• Serve as QA assessor/approver: resolve gaps, approve change plans, classifications, provide disposition strategy for GMP release
• Disposition Decision and status change in Oracle
• Assist in packaging validation and/or launch activities as needed
• Provide quality guidance for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified
• Assist in managing ongoing relationships with Contract Manufacturing Organizations (CMOs)
• Commercial Change Control
  • Serve as QA assessor/approver: resolve gaps, approve change plans, classifications, provide disposition strategy for GMP release
• Master and Executed Batch Record review and resolution of comments/issues
• Perform quality oversight of artwork/label review, approval, & implementation
• Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status

Master’s degree and 0-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field and 5-8 years of relevant work experience, or comparable background.

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at [email protected]. Please include the job title in the subject of your email.