Quality Assurance Document Systems Specialist - Opus Scientific

Location: Melville, NY
Categories: IT

Position Description

Quality Assurance Electronic Systems Documentation Administrator
Not only will the Administrator maintain control of electronic documentation systems but the Adminstrator will also have the opportunity to take on multiple roles to advance is or her career.
Learn more on the job by training new users and retraining others. Take another step towards a management role as the Senior Specialist reporting directly to the Quality Assurance Documentation Manager.
Learn job functions of QA specialist for specifications and quality assurance.
Develop systems that improve processes and access to documents.
Job Responsibilities:
· Act as Administrator or backup administrator of all QA electronic systems such as EDMS, ELN and LIMS.
· Maintain the SOP System for EDMS Documentation.
· Register and Release all validation protocols and or reports into EDMS.
· Edit validation protocols and or reports when necessary.
· Maintain the EDMS library of documents in a state of control.
· Coordinate and control all agency requests for electronically approved documents.
· Assist Regulatory Department in electronic document submission.
· Conduct EDMS training for all users.
· Conduct EDMS updates to the system.
· Set up and maintain all cGMP documentation in the BRF archive room.
Job Requirements:
· Minimum of three years Pharmaceutical cGMP environment experience
· Knowledge of 21 CFR Part 11
· NF and USP a plus
· BS Bachelor of Science, minimum AS, or AA
· Expertise Microsoft Word, Excel, Power Point
Job Preferences:
· BS in Chemistry or BS in Microbiology
· IT experience
Location: Long Island, NY
Compensation: $55K – $65K, Commensurate with experience/education.
Contact: For more information send your resume and cover letter to Ethel at jobs@opusscientific.com. Please write the title of the job “QA Administrator” in the subject line of the email for rapid processing.
Key words:
computer validation, quality assurance, electronic systems administrator, documentation specialist, quality assurance documentation, document validation, electronic document submission, validation technology, electronic records, electronic laboratory notebook, regulatory submissions, regulatory compliance, electronic regulatory compliance, electronic technical document, laboratory systems, electronic submissions, cGMP, GLP, SOP, FDA

How to Apply

jobs@opusscientific.com

Application Instructions / Send a Resume

Your Name:	Your Email:
Resume to upload: