Indivior
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 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 a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Learn more at
indivior.com
or visit our LinkedIn page at
Indivior .
Position Summary The Manufacturing Quality Assurance (MQA) Specialist – 2nd Shift is responsible for providing quality oversight to all manufacturing areas to ensure product quality and SOP/GMP compliance. The MQA Specialist works 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 performs routine environmental monitoring to assess the viable and non‑viable particulate levels within classified manufacturing rooms and support rooms.
Essential Functions
Required to be on‑the‑floor and present to provide quality oversight for all critical manufacturing processes. Able 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 to meet release scheduling.
Complete gown qualification and maintain status for entry into aseptic processing area. Demonstrate sound knowledge of aseptic gowning practices.
Perform aseptic gown training and certification sampling.
Identify deviations and ensure they are initiated by the appropriate personnel.
Perform AQL checks on product when necessary and maintain AQL qualification status.
Assess aseptic behavior inside the aseptic manufacturing area. Provide real‑time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation.
Conduct viable and non‑viable environmental monitoring throughout facility, including aseptic processing areas and classified manufacturing areas.
Collect facility waters and submit for testing.
Requisition materials, maintain 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 cGMP compliance and establish systems that identify opportunities for improvement and provide constructive suggestions to improve process effectiveness and heighten quality.
Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMPs, FDA, OSHA, and other regulatory agencies.
Minimum Qualifications
Bachelor’s degree in science or engineering from an accredited university.
Minimum one (1) year experience in the pharmaceutical industry (cGMP environment) and aseptic technique.
Ability to get gown certified within 30 days.
Physical requirements: standing and walking up to 8 hours, lifting or moving up to 35 pounds, reaching with hands and arms for up to 6 hours. Must be able to climb or balance, stoop, kneel, crouch, or crawl for up to 1 hour.
Good oral, written, and interpersonal communication skills.
Acceptable visual acuity test required for this position.
Competencies / Conduct
Embrace Indivior core culture principles.
Team support, collaboration, and success.
Praise core wins and empower others to maintain a quality mindset.
Always prioritize patient safety to provide safe and effective products.
Celebrate and embrace diversity, equity, and inclusion.
Proficient knowledge of manufacturing processes and standard operating procedures.
Benefits
3 weeks’ vacation plus floating holidays and sick leave; company closure from December 24th to January 1st.
401(k) and profit‑sharing plan with 75% match on first 6% contributions and profit sharing equal to 4% of eligible pay.
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.
Gym, fitness facility, and cell phone discounts.
Guiding Principles Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in everyday performance.
Compliance Obligations Indivior is committed to maintaining a workplace where employees are encouraged to raise concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:
Employee Obligations
Maintain unquestionable ethics and integrity under significant pressure.
Know applicable policies (Risk IQ) and adhere to them.
Speak up: If you see something, say something.
Manager Obligations
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 We are an equal opportunity employer. EOE/Minorities/Females/Vet/Disabled.
#J-18808-Ljbffr
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 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 a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Learn more at
indivior.com
or visit our LinkedIn page at
Indivior .
Position Summary The Manufacturing Quality Assurance (MQA) Specialist – 2nd Shift is responsible for providing quality oversight to all manufacturing areas to ensure product quality and SOP/GMP compliance. The MQA Specialist works 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 performs routine environmental monitoring to assess the viable and non‑viable particulate levels within classified manufacturing rooms and support rooms.
Essential Functions
Required to be on‑the‑floor and present to provide quality oversight for all critical manufacturing processes. Able 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 to meet release scheduling.
Complete gown qualification and maintain status for entry into aseptic processing area. Demonstrate sound knowledge of aseptic gowning practices.
Perform aseptic gown training and certification sampling.
Identify deviations and ensure they are initiated by the appropriate personnel.
Perform AQL checks on product when necessary and maintain AQL qualification status.
Assess aseptic behavior inside the aseptic manufacturing area. Provide real‑time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation.
Conduct viable and non‑viable environmental monitoring throughout facility, including aseptic processing areas and classified manufacturing areas.
Collect facility waters and submit for testing.
Requisition materials, maintain 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 cGMP compliance and establish systems that identify opportunities for improvement and provide constructive suggestions to improve process effectiveness and heighten quality.
Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMPs, FDA, OSHA, and other regulatory agencies.
Minimum Qualifications
Bachelor’s degree in science or engineering from an accredited university.
Minimum one (1) year experience in the pharmaceutical industry (cGMP environment) and aseptic technique.
Ability to get gown certified within 30 days.
Physical requirements: standing and walking up to 8 hours, lifting or moving up to 35 pounds, reaching with hands and arms for up to 6 hours. Must be able to climb or balance, stoop, kneel, crouch, or crawl for up to 1 hour.
Good oral, written, and interpersonal communication skills.
Acceptable visual acuity test required for this position.
Competencies / Conduct
Embrace Indivior core culture principles.
Team support, collaboration, and success.
Praise core wins and empower others to maintain a quality mindset.
Always prioritize patient safety to provide safe and effective products.
Celebrate and embrace diversity, equity, and inclusion.
Proficient knowledge of manufacturing processes and standard operating procedures.
Benefits
3 weeks’ vacation plus floating holidays and sick leave; company closure from December 24th to January 1st.
401(k) and profit‑sharing plan with 75% match on first 6% contributions and profit sharing equal to 4% of eligible pay.
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.
Gym, fitness facility, and cell phone discounts.
Guiding Principles Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in everyday performance.
Compliance Obligations Indivior is committed to maintaining a workplace where employees are encouraged to raise concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:
Employee Obligations
Maintain unquestionable ethics and integrity under significant pressure.
Know applicable policies (Risk IQ) and adhere to them.
Speak up: If you see something, say something.
Manager Obligations
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 We are an equal opportunity employer. EOE/Minorities/Females/Vet/Disabled.
#J-18808-Ljbffr