MQA Specialist - 3rd Shift

Indivior in; Raleigh (NC); On-site; USD 65,000 - 82,000; Full time

Benefits offered by this job

Starting salary with comprehensive ben

Job summary

Indivior is a global pharmaceutical company in Raleigh, NC seeking a Manufacturing Quality Assurance (MQA) Specialist for the 3rd shift. The role provides quality oversight across manufacturing areas, ensuring SOP/GMP compliance and proper documentation practices.

The specialist will review in-process batch records, resolve batch issues, and perform routine environmental monitoring while coaching aseptic technique to heighten product quality and patient safety.

Qualifications

• Bachelor's degree in science, engineering or equivalent experience.
• Minimum one year in the pharmaceutical industry with cGMP.
• Ability to obtain gown certification within 30 days.
• Strong communication and interpersonal abilities.
• Ability to meet physical requirements listed in the ad.

Responsibilities

• Provide on-the-floor quality oversight for core manufacturing processes.
• Address daily quality and environmental questions and communicate with management.
• Review in-process batch records and approve final batch records.
• Perform aseptic gowning, training, and assess aseptic behavior.
• Conduct environmental monitoring and ensure regulatory compliance.

Skills

Communication skills

Interpersonal skills

Quality assurance

Aseptic technique

Education

Bachelor's degree in science or engineering

Job description

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 OUD, and we are 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 an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.

POSITION OVERVIEW

The Manufacturing Quality Assurance (MQA) Specialist - 3rd shift 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.

HOW YOU'LL MAKE AN IMPACT

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 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 and 211, cGMP's, FDA, OSHA and other regulatory agencies.

WHAT YOU'LL BRING

• Bachelor's degree in science, engineering field, or equivalent experience.
• 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.

TITLE

MQA Specialist - 3rd Shift

WHO WE ARE

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 OUD, and we are 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 an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.

POSITION OVERVIEW

The Manufacturing Quality Assurance (MQA) Specialist - 3rd shift 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.

HOW YOU'LL MAKE AN IMPACT

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 issue 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 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 and 211, cGMP's, FDA, OSHA and other regulatory agencies.

WHAT YOU'LL BRING

• Bachelor's degree in science, engineering field, or equivalent experience.
• 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.

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.

HOW WE INVEST IN OUR PEOPLE

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:

Pursuant to various state Fair Pay Acts, below is a summary of compensation elements for this role at the company. The following benefits are provided by Indivior, subject to eligibility requirements.

Starting Salary:

$64,800-$81,500 USD

*Note actual salary is based on qualifications and experience

• Competitive PTO plus company closure from December 24th- January 1st
• Eligible to participate in Indivior's bonus program, based on company and individual performance
• Eligible to receive a yearly grant as part of Indivior's Long-Term Incentive Plan

• 401(k) and Profit-Sharing Plan- Company match
• U.S. Employee Stock Purchase Plan- 15% Discount

• Comprehensive Medical, Dental, Vision, Life and Disability coverage

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

• Adoption assistance

• Tuition reimbursement

• Concierge/personal assistance services

• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
• Wellness programs as well as other discounts and perks

OUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT

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 behavior.

Employee Obligations

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
• Model and reinforce a Speak Up culture on your team.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled are encouraged to apply!

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 change the duties of this position at any time.

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