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Senior QC Specialist, Method Validation Job in United States
Editas Medicine , United States

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Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Requires Traveling
No
Career Level
Telecommute
No
Qualification
Bachelor's Degree
Total Vacancies
1 Job
Posted on
Apr 10, 2021
Last Date
Jul 10, 2021
Location(s)

Job Description

Key Responsibilities amp; Accountabilities:

  • Author, review, and approve GMP documentation (SOPs, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing).
  • Author, review, and approve method transfers and method validations at vendors and internally as appropriate.
  • Generate and manage qualification of Reference standard, as needed.
  • Manage sample submission for contract manufacturing organizations (CMOs) for testing performed at Contract Testing Organizations (CTOs).
  • Review and interpret QC testing data and/or Biologics analytical methods generated by vendor test labs.
  • Support vendor OOS/Deviations/Investigations, verifies that data meets current specifications, generates COA(s), and track cycle time metrics, captures related deviations, OOS, CAPAs, atypical results, change controls.
  • Identifies and communicates routine technical problems and data and vendor issues within the scope of responsibility.
  • Makes and understands basic decisions within scope of responsibility.
  • Enters data into a validated data source.
  • Prepares protocols/reports as appropriate/necessary.
  • Coordinates with departmental peers on project work as appropriate.
  • Trends batch result, reference standards and data as appropriate.
  • Initiate workflows for protocol and report uploads/approvals in relevant electronic documentation systems Coordinates with departmental peers on project work as appropriate.
  • Reviews QC testing data and/or Biologics analytical methods generated by vendor test labs. Downloads data from vendor sharepoints/databases/LIMS.

Requirements

Knowledge, Skills amp; Capabilities:

  • Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
  • A strong understanding of applicable regulations and guidelines pertaining to pharmaceutical product development. manufacturing, testing and clinical operations.
  • Previous experience in Quality Control and/or analytical development is preferred.
  • Should have experience in a broad variety of analytial testing techniques, including HPLC, UV, CE, Bioassay, PCR, Gel Electropherisis, GC-MS, Potency, and biological assays.
  • Proficiency in the use of Microsoft Office, PowerPoint, electronic document and Training systems.
  • Experience with management and implementation of e-Quality Systems.
  • Good verbal and written communication skills.
  • Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives.
  • Demonstrated organizational skills to managing multiple projects and priorities.

Education amp; Relevant Work Experience:

  • BS Degree in Biology, Chemistry or other Life Sciences
  • Minimum of 6 years of related experience
  • Experience in Quality setting with particular interest in stability studies and data trending

Physical amp; Travel Requirements:

  • Minimal travel may be required



Job Specification

Editas Medicine

Information Technology and Services - Cambridge, United States