MQA Specialist - 2nd Shift

Socket.dev; Raleigh (NC); On-site; USD 65,000 - 82,000; Full time

Benefits offered by this job

PTO

Medical/Dental/Vision

Tuition reimbursement

Adoption assistance

Wellness programs

Job summary

Indivior is seeking a Manufacturing Quality Assurance (MQA) Specialist for the 2nd shift to provide quality oversight across manufacturing areas and ensure GMP compliance. The role involves in-process batch review, handling deviations, and performing routine environmental monitoring in classified rooms.

The ideal candidate has a science/engineering degree with 1+ year experience in pharma (cGMP) and aseptic gowning.

Qualifications

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

Responsibilities

• Be on-the-floor to provide quality oversight for all critical manufacturing processes.
• Address daily quality concerns related to operating and environmental issues.
• Communicate complex issues to Management personnel.
• Complete in-process batch record review and timely final batch record approvals.

Skills

Good communication

Education

Bachelor's degree in science/engineering

Job description

TITLE: MQA Specialist - 2nd 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 forOUD,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 toexpandits heritage in thiscategory. Headquartered in the United States in Richmond, VA,Indivior employs approximately 800 individuals globally.

POSITION OVERVIEW

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 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.

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:

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
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health,Dependent Care and Limited Purpose Flex Spending and HSA options

• Adoptionassistance

• Tuition reimbursement

• Concierge/personalassistanceservices

• 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 tomaintaininga 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/Disabledare encouraged to apply!

The duties and responsibilitiesidentifiedin this position description are considered essential but are not limited to only those outlined. Theemployeemay perform other functions that may be assigned. Managementretainsthe discretion to add or change the duties of thisposition at any time.

Want to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.