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Senior QC Analyst (RM/Testing) 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

Editas is seeking a Sr. Quality Control Analyst (Raw Materials/QC Testing) to join the Quality team and play a significant role in the support of our product pipeline. Reporting to the QC Manager, Internal Operations, this position will be responsible for Raw Materials release testing as well as in process and final product release testing at Editas Medicine in Cambridge, MA/Azzur (Cleanrooms on Demand) facility in Waltham, MA.

This position will be responsible for the in a variety of analytical testing including, but not limited to Flow Cytometry ,HPLC, Bioassay, PCR, Gel Electrophoresis and compendial testing.

Candidates must have hands-on experience and demonstrated organizational skills in a regulated analytical/QC environment.

Key Responsibilities amp; Accountabilities:

  • Oversee sampling and storage of QC samples and maintain retain inventory.
  • Maintenance of laboratory equipment/instrument and systems to ensure compliance.
  • Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures such as Flow Cytometry using BD FACSCanto, Protein Assays, Q-PCR, pH,Osmolality, etc.
  • Aseptic technique and working with Cell Maintenance, Cell Passaging, Cell Counting, Cell culture and live viruses.
  • Responsible for protocol and report generation, as required.
  • Perform sample management such as receipt, inventory, tracking
  • Coordinate shipment of samples to contract testing laboratories, as required.
  • Trend data and aid in compilation of trend reports.
  • Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
  • Maintain QC lab and related systems to ensure compliance with industry standards.
  • Responsible for change controls, OOS and deviations related to QC raw materials, including investigations, as required.
  • Work in compliance with cGMP’s, effectively demonstrates an understanding of cGMP's and how it applies to specific responsibilities
  • Communicates inter-departmentally and with outside contacts to solve technical issues
  • Exercises sound judgment and decision making when problem solving
  • Revise Quality System procedures
  • Perform other duties, as assigned.


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.
  • Working knowledge of current Good Laboratory Practices (GLP 21 CFR Part58), Good Manufacturing Practices (cGMP 21 CFR Part 210/211), and Electronic Records; Electronic Signatures (21 CFR Part 11).
  • Proficiency in the use of Microsoft Office, PowerPoint, electronic document and Training systems.
  • Experience with management and implementation of e-Quality Systems.
  • Presentation development and performance skills is a preferred
  • 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:

  • Bachelor’s degree in biology, chemistry or other life science and at least 5-8 years of relevant industry experience in Quality Control in a Pharmaceutical/Biotech GMP environment.
  • Authorization to work in the United States indefinitely without restriction or sponsorship

Job Specification

Editas Medicine

Information Technology and Services - Cambridge, United States