Overview

What’s in it for you:

Meaningful, long-term career growth
Executives, managers, and mid- and entry-level employees collaborate in team discussions and stand-up meetings
Strategize solutions as one team, and network across departments and locations
Be encouraged to share your skill-sets and learnings with like-minded colleagues

Job Type : Full Time
Location : Cumberland Foreside, Maine
Pay : Great Pay + Benefits!
Job Description
The Quality Assurance Specialist I will be responsible for assisting the QA/RA Manager with document control, batch records, review of quality records, audits, and updating databases.

What you will be doing:

Assisting in the preparation, review and organization of batch records and QA files
Assisting in scanning of QA records, manufacturing SOPs, Device History Records, Design History Files, Incoming inspection records and other files as needed.
Assisting with all aspects of document control
Updates to tables/databases to support QA
Assisting with quarterly and/or yearly reviews, updates, and filing of QA records
Assisting with or performing quality audits
Assisting with the execution of periodic Department SOP reviews and maintaining records of the reviews
Ensures orderly storage and expedient retrieval of all documentation according to Good Manufacturing Practice (GMP) regulations.
Performing incoming inspections, as applicable.

Experience you will need:

Ability to create and maintain trend charts supporting, monitoring, and measuring activities
Knowledge of Electronic Document Systems preferred.
Knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) preferred

Our client asked me to submit 3 great people within the next few days. We work directly with the hiring manager and can arrange interviews within a few days

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