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MQA Specialist - 1st Shift

Title: MQA Specialist-1st 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 opioid use disorder (OUD). 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 OUD. Indivior is dedicated to transforming OUD 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. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. 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.

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.

· Review and approve critical work orders.

· Perform logbook reviews and verification of logbook reviews.

· 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 inspection of retain samples.

· 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.

· Provide good aseptic technique and gown retraining to personnel as required per the RPN program.

· Provide backup support to the environmental monitoring group as needed.

· 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 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.

MINIMUM QUALIFICATIONS:

· Bachelor’s degree in science, engineering field, or equivalent experience.

· Minimum one (1) year’s experience in the pharmaceutical industry (cGMP environment) and aseptic technique

· Ability to get gown certified within 30 days

· Physical requirements include standing and walking up to 8 hours (4 hours at a time for aseptic processing area), lifting or moving up to 35 pounds and reaching with hands and arms up to 6 hours. Must be able to climb or balance, stoop, kneel, crouch, or crawl up to 1 hour.

· Good communication (oral, written) and interpersonal skills are necessary.

· An acceptable visual acuity test is required for this position.

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

· Embrace Indivior core culture principles.

· Embrace the dynamics of team support, team collaboration and team success.

· Celebrate the core wins of the organization and empower others to sustain a quality mindset.

· Always have patient safety at the forefront in the efforts to provide safe and effective products to enhance and improve lives.

· Celebrate and embrace diversity, equity and inclusion.

· Proficient knowledge of manufacturing processes and standard operating procedures.