Quality Specialist II

at  Thermo Fisher Scientific

PROVIDE TECHNICAL WRITING SUPPORT THROUGH CONDUCTING DOCUMENT REVIEWS AND USE PRACTICAL LABORATORY SCIENTIFIC WORK EXPERIENCE AND TECHNICAL WRITING SKILLS TO REVISE TECHNICAL SOPS; THIS REQUIRES STRONG TIME MANAGEMENT, PRIORITIZATION, AND INTERPERSONAL SKILLS TO COORDINATE CROSS-FUNCTIONALLY WITH SCIENTISTS AND PRINCIPAL INVESTIGATORS AS WELL AS EXCELLENT LISTENING, INTERPRETING, AND WRITING SKILLS.

Assist with revisions to Quality, Operations and EHS SOPs as needed. Assign Master Control job codes and training correctly. Participate in Internal Audits, and as an Internal Auditor. Support Quality Management System and Quality Department with other responsibilities as assigned.

EDUCATION & EXPERIENCE

Bachelor’s degree is highly preferred, Associate/High School and/or combination of education and experience may be considered.
At least 2 years of scientific laboratory and/or manufacturing work experience required.
Prior work with document control in a GMP manufacturing environment is preferred.

JOB DUTIES, RESPONSIBILITIES AND AUTHORITIES

The role has the following responsibilities and authorities as assigned by the Manager:
Responsible for efficiently processing Document Change Requests (DCRs), including routine data entry, coordinating document review/approval/release per department SOPs.
Use MasterControl to manage all document reviews and workflows.
Responsible for document writing and revision processes to be progressed in a timely manner by all parties; this requires strong communication, follow up and influencing skills.