|Location: Rahway, New Jersey||Salary: US$65 - US$70 per hour|
|Sector: Pharma & Health||Type: Contract|
|Reference #: CR/076857_1611088647|
Red Commerce has a direct client who is looking for a Quality Assurance CSV Analyst with Big Pharma experience for a 12-18 Month contract. Will start 100% remote, however they hope to have this resource onsite in Rahway, NJ once Covid ends. Big Pharma experience is a must - GMP Quality person would be a huge plus.
- Should have manufacturing experience
- this is research - someone with research quality is very helpful; not just supply
- Might be working with "one of a kind" never been done before - can't be super rigid.
- Able to work in a "non defined" area - if doing a change control to retire a piece of lab equipment, that would be easy. If doing "factory of the future" they run into situations where no one has the answer. They want people are inquisitive and can handle the "never been done before"
- GLP and GMP
- GXP activities
- Day to day work
- Support applications and LIMS, reviews of documents
- Change controls
- Go through loop checks
Job Overview - Basic Functions & Responsibility:
Reporting to the team leader of the Global Development Quality (GDQ) | Computer System Validation (CSV) Center of Excellence (CoE), the incumbent is responsible for QA oversight of planning, execution and summarization of CSV activities.
The CSV activities requiring QA oversight will deal with a broad array of systems and areas. The general requirement will be in the review of System Development Life Cycle (SDLC) documentation for standalone COTS laboratory instruments, SDLC and change control documentation for automation systems and automated facilities and equipment and general QA expertise to support area operations. Specifically, SDLC deliverables to be dealt with are: Quality Assurance Plans, Configuration Specifications, Requirement Specifications, supporting verification and/or testing against requirements (all types of testing documentation), Trace Matrices, QASR and other summary documentation as well as change control records, retirement plans, standard operating procedures and system documentation indexes.
Participates, assists and provides QA oversight in the development of SDLC deliverables supporting all of the GMP operations at the Rahway, NJ site to ensure applicability and compliance with internal and external policy and regulations. Reviews various GMP deliverables for conformance with SDLC baseline criteria and other internal and external regulations. Identifies and resolves issues interfering with execution of deliverables. Implements practices designed to eliminate or minimize reoccurrences.
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