Quality Assurance Specialist

Posting Date 3 weeks ago(1/31/2018 2:34 PM)
Requisition ID
Job Location(s)
Bloomington IN United States
Less than 10%
Shift Type
Position Type
Full Time
Cook Regentec LLC


The Quality Assurance Specialist at Cook Regentec will work under the Cook Biodevice Quality Management System (QMS) to ensure the accuracy, quality and integrity of the quality system by managing company documents and the document control center. Responsibilities include process maintenance, and performance of, investigation management (CAPA and Deviations), risk management, document control, Quality Management Review, internal and external audits etc. 


• Perform procedures as required under the QMS
• Establish/maintain processes to ensure that documents (e.g., policies, SOPs, forms, templates) are controlled and managed to support the Quality Management System
• Ensure that records used to demonstrate compliance are controlled and available for audits
• Assist authors with the creation and revision of documents through completion of document change requests
• Write or update procedures under the responsibility of QA
• Support record retention management
• Support CAPA system management
• Support Feedback and Complaint system management
• Complete, participate, review and approve investigations related to CAPA, Deviations, Feedback, and Complaints as necessary
• Review documents for approval as directed.  These may include audit reports, supplier qualifications, reports, QMS documents, and manufacturing batch records

• Monitor, track, and evaluate Quality System process data
• Facilitate the Quality Management Review meetings
• Support change control system management
• Complete, participate, review and approve change control as needed
• Apply the understanding of the Quality Policy Manual in carrying out job responsibilities
• Complete records accurately for the duties trained
• Assist with internal audits of the quality system to determine the effectiveness and dependability of the system
• Assist in internal and external assessments including writing assessment reports as needed
• Maintain current knowledge of FDA, ISO and industry requirements
• Responsible for reporting quality issues to the QA Manager


• Bachelor’s degree required
• Experience working in GMP environment preferred
• Experience working in a regulated industry, such as pharma, medical device, or biologics preferred
• Excellent and effective English written and oral communication skills

• Experience working with document management/control systems.
• Knowledge in current Good Documentation Practices preferred


Physical Requirements:

• General office environment
• Must be able to sit for long periods of time
• Less than 10% travel

• Position requires flexibility to work at Indianapolis and Bloomington locations


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