MQA Specialist - 2nd Shift

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* Title:

** MQA Specialist - 2nd Shift
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* Location:

** Raleigh, NC
* 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 21

CFR Parts 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
* Bachelor’s degree in science, engineering field from an accredited university required
* Minimum one (1) year 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.
* 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.
** BENEFITS:
** Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

Health, Dependent Care and Limited Purpose Flex Spending and HSA options

Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:

Risk IQ:
Know what policies apply to your role and function and adhere to them. The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined.  The employee may perform other functions that may be assigned.  Management retains the discretion to add or…