Analyst IV, Dossier Data Integrity, Quality Control Operations

Job Title: Analyst IV, Dossier Data Integrity, Quality Control Operations

Job Description

Overview:

The Analyst IV Dossier Data Integrity in Quality Control Operations – Contractor is an individual contributor responsible for ensuring the high standards of quality and compliance are met in support of commercialization of Alnylam programs. The Analyst IV Dossier Data Integrity in Quality Control Operations – Contractor, is responsible to assure the completeness, consistency, and accuracy of regulatory filings, laboratory data and reports. This is accomplished by reviewing regulatory filings against source methods or reports as specified by Standard Operating Procedures. This position is flexible for remote working with some on-site presence as needed. Some travel to CMO/CTL sites may be necessary.

Key Responsibilities (including but not limited to):

• Verify the integrity and traceability of regulatory dossier sections. Review regulatory dossier sections against associated reference methods and reports for accuracy in data reporting/transcription.

• Review analytical data for accuracy in data reporting/transcription and for complete and correct entries of all associated references. Verify the integrity and traceability of all data generated and reported.

• Review data documented by laboratory personnel within laboratory notebooks, worksheets, logbooks (e.g., instrument use and maintenance logbooks) along with respective electronic data.

• Review complex notebooks involving analytical method validation, verification and transfer testing and ensure that the testing is conducted as per approved protocols and methods.

• Review audit trail to ensure that the electronic data were generated according to applicable procedures.

• Ensures that all the affiliated data including electronic data and respective notebooks/logbooks are complete and reviewed.

• Discuss with clients when necessary to resolve all required corrections to analytical data or reports.

• Works in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). Consult with management regarding priority of assignments. Provide communication to management of any deviations/discrepancies noted during the review process. Provide feedback and suggest ideas to improve the review process.

• Perform any other duties as assigned by the management. 

Qualifications:

• B.S. in chemistry, biology, or biochemistry, or related scientific field.

• Pharmaceutical/Biotech industry experience with 5 years in a GMP Quality Control function or equivalent, relevant industry experience with demonstrated increase in responsibility

• Experience in method transfer and/or analytical method implementation; solid understanding of method lifecycle management and phase-appropriate approach

• Demonstrated technical writing skills, with preference for technical writing of investigations

• Proficient in data analysis and interpretation, with excellent attention to detail to inform decision-making

• Solid problem-solving skills and experience in conducting investigations and implementing CAPA

• Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously

• Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment

• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred