Quality Control Senior Analyst II

Job Description

JOB TITLE:Quality Control Senior Analyst II

LOCATION:50 Northern Ave, Boston, MA 02210

OPENINGS:1

DUTIES: Perform data review, manage critical document tracking, and be a point of reference to ensure content in regulatory filings matches source documentation. Drive to work with both internal and external partners to define and manage the ongoing cGMP testing of cell and gene therapy products from pre-clinical through post-approval lifecycle management. Contact subject matter experts and relevant parties to recover documents required for regulatory submissions and background source information. As Point of Contact with Contract Testing Lab, build the partnership and oversee testing progress and deadlines. Reconcile documents recovered against project plans / trackers to assure targets have been recovered and identify gaps where documents are not available. Manage the movement of documents from SharePoint to a Document Repository (QDoCCs and/or Veeva). Verify data in regulatory submissions matches data in source documents. Create and manage datasets, including verifying the data against source documents. Collaborate with in house quality counterpart and with CxOs. Monitors CxOs oversight activities and assesses for continuous improvement. Work with internal and external subject matter experts and other relevant disciplines to manage and resolve scientific, technical, or quality issues and improve study consistency, quality, efficiency, and effectiveness. As part of an overall Program Team, participate in client meetings regarding sample data management as the Quality Control SME in this area. Evaluating/tracking/trending results and generating milestone status updates and reports ensuring accuracy and GMP compliance. Telecommuting permitted up to 40%.

REQUIREMENTS: Employer will accept a Bachelor's degree in Biology, Chemistry, Health Science, Pharmaceutical Science, or related field and (2) two years of experience in the job offered or in a Quality Control Senior Analyst-related occupation.

Position requires demonstrable experience in the following:

• Setting up stability programs for cell banks

• Data management and review of stability and QC cell therapy programs

• Performing, executing, and vetting cell therapy related testing

• Strong GMP knowledge

• Managing project timelines and operations (scheduling for stability timepoints)

• Comprehension of regulatory submissions and filings

• Support and participate for BLA filings

• Lead laboratory deviations/investigations

• Authoring and approving documentation (SOP's/Memos/Risk Assessment)

• Leading and supporting CAPA/ Continuous Improvement initiatives

• Knowledge of performing QC tests for a GMP cell therapy program, including flow cytometry, PCR, and ELISA

• Knowledge of using FTIR

Telecommuting permitted up to 40%.

CONTACT: Send Resume to Sarah Hadjian at sarah_hadjian@vrtx.com. Reference 12140.682. EOE.

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