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Technical Writer II - Pharma

Company:
Pioneer Data Systems, Inc.
Location:
Andover, Massachusetts, United States
Salary:
$32-$37/hr
Posted:
April 15, 2019

Description:

QC Technical Writing includes writing and revising technical documents (procedures, test methods, raw material specifications) for new and existing raw materials, documentation support, LabWare Laboratory Information Management System (LIMS) support, visual management, and continuous improvement activities. The candidate will be responsible for documentation support as an individual and through collaboration with laboratory subject matter experts (SMEs). Organize and prioritize workload with manager to meet all timelines and deliverables in the support of the plan of record and to ensure compliance.

Major Role Responsibilities:

Revise and author GMP documents

Create and submit change requests to laboratory information management system (LIMS) builds to LIMS team and review work completed

Support continuous improvement projects and actions

Manage projects and coordinate timelines with stakeholders

Requirements:

A BA/BS degree in science, engineering, computer science, or related technical discipline.

Minimum 3-5 years pharmaceutical/biopharmaceutical experience in a relevant GMP role such as QC or QA

Past experience working with QC documentation in the biopharmaceutical field is preferred

Comments:

Will be in the QC Raw Materials group

This is not a testing role

Will revise technical documents

Looking for QC lab background

GMP pharma experience

Document management systems is highly preferred

Basic computer skills with MS office experience

QC background with experience in authorizing documents

Change documents

Independent and self motivated

communicate across teams

3-5 years experience with document review, change, authorizing

Thorough hands on experience, not just exposure to revision and authoring GMP documents

NO OT

looking for high level of professionalism and can communicate well.