QA Associate Specialist – Document Control

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


Summit, United States TSR Consulting Services, Inc. Full time

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading pharmaceutical company is hiring a QA Associate Specialist – Document Control on a contract basis. Please only local candidates to Summit NJ.

Work Location: Summit NJ

Pay: $30-31/hour W2

Required Skills:

• Document Control & Reporting experience

• Veeva experience preferred

• Technical troubleshooting

• The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP

Document Control operations for Cell Therapy organization

• Managing an electronic document system which includes reviewing and approving document

change requests, troubleshooting and releasing documents to an effective state

• May write and revise document control procedures including participating in the

development and roll-out of document control tools

• Follow Policies, SOPs, and work instructions to support the document approval process,

assign effective dates and training workflows, and archive documents and document change

requests

• Assist with cross-training of Document Control personnel and customers to ensure adherence

with procedures

• Execute the process and procedures for identifying, collecting, distributing and filing the

controlled documents for the site

• Generate document management system reports for Quality Council metric reporting

• Support internal and external audits and regulatory inspections if required

• Assist with document retrieval /organization support during regulatory inspections

• Provide communication as to the status of Quality Systems deliverables to customers,

management, and stakeholders

• Some technical writing skill set and be able to critically review documents while effectively

inputting and expressing Quality principles

• Relevant document control experience in a cGMP/FDA regulated environment

• Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality

Systems (e.g. Document Management System, Quality Management System)

• Experience interacting with FDA or other regulatory agencies strongly preferred

• Strong knowledge of cGMPs and domestic regulatory requirements

• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems,

validation, etc.)



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