HI,

Hope you are doing great!

This is Harry from Dynamic Enterprise Solutions. We have urgent requirement 
with one of our Direct client's (No hidden Layers) , please review below job 
description and let me know your interest



Position ID: DYESJP00020346

Title: Technical Writer - Quality Systems
Duration: 24 months
Location/Site: North Chicago, IL





Locals preferred - Hybrid Remote Role



Description:

Job Title: Senior Investigation Writer
Department: Quality
Onsite North Chicago 5 days a week
2 year contract
3-5 years experience required


Reports to: Quality Systems

Job Responsibilities:
List all major responsibilities of the position in order of importance and 
priority to the overall job. Describe the outcome that must be produced in a 
accomplishing the job. Each supports the overall purpose of the job.

*          Responsible for instrument support activities including access 
management, audit trail review, annual account recertification, qualification 
and validation support, risk assessments and data integrity risk assessments 
(DIRA).
Responsible for instrument integration with LIMS (Laboratory Information 
Management System), including asset integration, automation workflow support, 
and calculation support.

*          Primary Quality liaison between site quality and other areas of a 
plant operation such as MS&T, Supply Chain, Operations, Incoming Quality, 
Engineering, Third Party Manufacturers (TPM),Third Party Contractors(TPC), etc.

*          Responsible of performing investigation activities when an exception 
event occurs in the manufacturing, incoming lab, validation, microbiology, 
stability, or complaints area.
Assess product impact, conduct through analysis and make informed and accurate 
recommendations of the implication of the exception event.
Knowledge/ Education Required: List the minimum education, skills, 
requirements, practical knowledge, etc., needed to qualify.

*          Bachelor degree, preferably in Engineering or Science.



Experience Required:
List the minimum experience needed to qualify. Please include the position 
titles or descriptions of experience and required years.

*          Three to Five (5) years of experience within the Pharmaceutical 
Operations or GxP environment

*          Effective verbal and written communication skills

*          What type of environment is this person working in?
o Individual Setting





Thanks & Regard's

Harry John
Dynamic Enterprise Solutions Inc
1801 Hicks Rd, unit A
Rolling Meadows, IL -60008
(847) 701-5896 /(c) 224-635-0898




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