Overview

QA Documentation Specialist Jobs in Durham, NC at The Fountain Group

Title: QA Documentation Specialist

Company: The Fountain Group

Location: Durham, NC

Currently I have an opening for a Documentation Specialist located in Durham, NC. Details for the position are as follows:

Job Description:

Provide documentation support for vaccine production activities.

Review batch record, logbooks and electronic logbooks for errors and partner with Production, Quality, and other personnel to correct such errors and provide clarification as needed.

Support process documentation changes and improvements which includes updates to batch records and standard operating procedures (SOPs).

Effectively maintain and use metrics for the manufacturing shop floor execution documentation program.

Support process documentation deviation investigations to provide meaningful immediate and preventative actions and reduce the deviation generation rate.

Use standard systems including MS Word, Excel, PowerPoint, Outlook, Teams.

Documentation Specialist will serve on the Manufacturing Support Team working with shop floor production personnel and interfacing with Technical Support and Quality Operations and must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation.

The position requires great attention to detail, a command of good documentation practices (GDP) and the ability to design and strengthen documentation that satisfies Quality requirements.

HS, AS, or BS graduate with QA, documentation, and/or administrative experience within GMP/Pharma.

Technical Information:

Pay: $27-29 hourly

6-month contract, potential for extension

Onsite, M-F, 8am-430pm

Upload your CV/resume or any other relevant file. Max. file size: 800 MB.