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Reference # : 17-01708 Title : Excellent Job Opportunity for the position of QC Lab LEQ Validation Technical Writer I (6004293)
Location : Framingham, MA
Position Type : Contract
Experience Level : Start Date / End Date : 01/03/2017 / 12/16/2017  
Job Title: QC Lab LEQ ValidationTechnical Writer I
Work Location: Framingham, MA
Length of Assignment: 12 Months
Client: A Big Pharmaceutical Company

Job Description:
Prepare rough drafts of the protocol and technical report documentation for review with subject matter experts, project staff and/or customers.
Edit, standardize, or revise material prepared by other writers or subject matter experts.
Author protocols and technical reports for Laboratory Equipment Qualification (IQ, OQ, and PQ) according to company policies.
Assist multiple teams of technical experts in the technical writing of Laboratory Equipment Qualification
Prepare binders containing all relevant documentation. Organize documentation and cross-reference documents as necessary.
Route final documents for the appropriate approvals.
Requires working with Quality Control staff that will provide document redlines and review completed work.
Revisions of Laboratory Equipment Qualification documentation must be done utilizing defined content and formatting requirements. Ensure cGXP compliance in all documentation.
Investigate and document nonconformances in a timely manner.
The Technical Writer must be familiar with Microsoft Office products including Word, Excel, and PowerPoint.
Prior experience with Livelink a plus.
This person should be very familiar with documenting Laboratory Equipment Qualification / Validation studies, specifically pertaining to Quality Control.
Familiarity with cGMP is required.
Familiarity with 21CFR part 11 validation automation systems is required.
Technical writer will be trained in company SOP documentation standards, templates and practices.

Required Skills:
Technical writer must write in a concise and easy-to-read manner.
The Technical Writer will create and revise Laboratory Equipment Qualification / Validation Protocols and Reports from input of subject matter experts.
Excellent writing and editing skills.
Able to actively listen to what other people are saying and ask questions as appropriate.
Able to work with new material or information to grasp its implications.
Able to type 50 - 60 words/min Proficient with MS Word, Excel, and PowerPoint
Knowledge of lab-based data management systems preferred
Experience with HPLC, Dionex, GC, LCMS, UVVis Spectroscopy and empower software a plus.

Bachelors' Degree in Life Sciences discipline and 2 years' experience in cGMP environment
Bachelor's Degree required.

Interested candidates can share their most updated resume at or they can reach out to me on #973-967-3412 Ext: 3412