Job added in hotlist
Applied job
Contract job
Recruiter job
Employer job
Expanded search
Apply online not available
View more jobs in New Haven, CT
View more jobs in Connecticut

Job Details

Validation / Quality position available

New Haven, CT

Apply for this job

6 hit(s)  


Job Description
Our client is currently seeking a Validation / Quality consultant for a remote role.
This is 100% remote but must be able to work directly as a w2 without sponsorship.

The IT Quality Operations Manager is responsible for ensuring that quality records that support IT/Computerized Systems are in compliance with industry regulations, internal procedures and industry best practices.

Provide guidance to maintain established GxP computerized system throughout their life cycle.

Ensure the timely review and approval of quality systems records to meet department and corporate metrics.

Communicate with all levels of the organization, execution teams and compliance stakeholders to assure that Quality deliverables are sufficiently planned and executed within specified timelines.

Support daily Quality Assurance Operations, including but not limited to, creation, revision and implementation of documentation to support Computer Systems operations.

Support for Quality Improvement Plans, including the creation and revision of SOPs to improve the existing SDLC and Computer Systems Validation Programs.

This role may be required to support Computer Systems Validation projects, wherein the individual will review and approve computer system validation deliverables to meet demand, as appropriate.

Skill Requirements

* The IT Quality Operations Manager has thorough knowledge of global regulatory requirements for computer systems validation, including ERES (Part 11 and Annex 11) and predicate rules.

* The Technical knowledge of TrackWise and ServiceNow preferred

* Extensive knowledge of QMS, including Deviations, CAPAs, Effectiveness Checks, Change Controls.

* Analytical thinker who can think able to identified problems and use critical thinking to identify root cause. Formal root cause analysis training, preferred.

* High-level understanding of IT infrastructure qualifications and computer systems validation best practice principles.

* Skilled in Technical Writing.

* High-level knowledge of computer systems interfaces, architecture and design.

* Excellent communication style that assures clear and concise communications.

* Experience in working with geographically and culturally diverse teams, preferred.


* 5-7 years of direct QA oversight experience for QMS support for GxP IT/Computerized Systems.

* 3-5 years of CAPA and deviation management experience using TrackWise

* 3-5 years of change management experience using TrackWise

* 2-4 years of experience technical writing

* 2-4 years of experience reviewing computer systems validation deliverables from a quality perspective

* 3-5 years in a GxP in biopharmaceutical / pharmaceutical industry.

* Knowledge of GAMP5, System Development Life Cycle (SDLC) and IT infrastructure, including SaaS, data quality, data integrity and data management best practices.


* BS/BA degree in Engineering, Chemistry, Biology and/or science related field; advanced degrees preferred.

Joy Provenzano, VP- Recruiting, The Judge Group

90 Matawan Rd, Suite 102, Matawan, NJ 07747
office (732) 497-4246 l **** |


Description: Description: cid:****CA4C0

Let's connect on linkedin: ****

Click to learn more about Judge's Technology, Talent & Learning Solutions

people powered business solutions

Company info

Sign Up Now -

Similar Jobs:
Chemistry Teacher
Location : New Haven, CT
Openings as of 7/13/2018Certified TeacherChemistry Teacher JobID: 3359 Position Type: Certified Teacher/ChemistryDate Posted: 7/12/2018Location: Engineering & Science Univ. Magnet School (6 - 12)  Description: Position requir...
Process Technologist- Naugatuck CT 06770
Location : Naugatuck, CT
Process Technologist- Naugatuck CT 06770 Kelly Services • Naugatuck CT Job #700365995 Process Technologist- Naugatuck, CT06770 Position Scope Our client is looking for an experienced, creative and hard-working process technologist...
I was very pleased with the ChemistryCrossing. I found a great position within a short amount of time … I definitely recommend this to anyone looking for a better opportunity.
Jose M - Santa Cruz, CA
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
ChemistryCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
ChemistryCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 ChemistryCrossing - All rights reserved. 169