MQA Specialist (2nd Shift)

TITLE:

MQA Specialist (2nd Shift)

Title: MQA Specialist- 2nd Shift

Reports To: MQA Manager

Location: Raleigh, NC

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category.

Indivior was founded to help tackle the opioid crisis, one of the largest and most urgent public health emergencies of our time.  Our purpose is to bring science-based, life-transforming treatments to patients.  We strive to help eliminate the stigma of addiction.  We take our role as a responsible steward extremely seriously and commit ourselves to cultivating our unique culture and highest standards of integrity.

We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation.  We engage at all levels across the addiction treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups to raise awareness and educate about addiction as a chronic, relapsing disease.

Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

POSITION SUMMARY:

The Manufacturing Quality Assurance (MQA) Specialist is responsible for providing quality oversight to all manufacturing areas to ensure product quality and SOP/GMP compliance.  The MQA Specialist will work closely with production personnel to complete in-process batch record review, resolve batch related issues, and ensure proper good documentation practices.  In addition, the MQA Specialist will be responsible for performing routine environmental monitoring to assess the viable and nonviable particulate levels within classified manufacturing rooms and support rooms.   

ESSENTIAL FUNCTIONS:

The responsibilities of this job include, but are not limited to, the following:

• Required to be on-the-floor and present to provide quality oversight for all critical manufacturing processes.  Ability to make independent decisions regarding quality related concerns or issues.
• Address daily quality concerns and questions related to operating and environmental issues. 
• Clearly communicate complex issues to Management personnel.
• Work closely with production personnel to complete in-process batch record review, resolve batch related issues, and complete timely final batch record approvals in order to meet release scheduling.
• Complete gown qualification and maintains status for entry into Aseptic processing area.  Must be able to demonstrate a sound knowledge of aseptic gowning practices.
• Perform aseptic gown training and certification sampling.
• Identify deviations and ensure the deviations are initiated by the appropriate personnel.
• Perform AQL checks on product when necessary and maintain AQL qualification status.
• Perform and document assessments of aseptic behavior inside the aseptic manufacturing area.  Must be able to provide real-time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation.
• Conduct viable and nonviable environmental monitoring throughout facility, including aseptic processing areas and classified manufacturing areas. 
• Collect facility waters and submit for testing.
• Requisition of materials, maintaining inventory, and receive and store prepared media. 
• Enumerate bacteria and report excursions, if required.
• Perform additional duties and responsibilities as assigned.
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in cGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 an