MQA Compliance Specialist

TITLE:

MQA Compliance Specialist

Title: MQA Compliance Specialist

Reports To: MQA Manager

Location: Raleigh, NC

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). 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 SUD. Indivior is dedicated to transforming SUD 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.

Indivior was founded to help tackle the opioid crisis, one of the largest and most urgent public health emergencies of our time. Our purpose is to bring science-based, life-transforming treatments to patients. We strive to help eliminate the stigma of addiction. We take our role as a responsible steward extremely seriously and commit ourselves to cultivating our unique culture and highest standards of integrity.

We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation. We engage at all levels across the addiction treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups to raise awareness and educate about addiction as a chronic, relapsing disease.

Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

POSITION SUMMARY:

The Manufacturing Quality Assurance (MQA) Compliance Specialist is responsible for investigating Quality nonconformances and reviewing and approving CAPAs, change controls, and nonconformances. The MQA Compliance Specialist is also responsible for the review of systems release documentation, inspection of retain samples, and monthly logbook verifications. 

ESSENTIAL FUNCTIONS:

The responsibilities of this job include, but are not limited to, the following:

• Interact with multiple functional groups to understand the problem, identify root cause(s), and assist in identifying appropriate corrective and/or preventive actions to prevent reoccurrence.
• Review supporting documentation including batch documentation, ancillary documentation, test results / CoAs, product specifications, training records, SOPs, calibration records, packaging and validation protocols, and other technical documents in support of investigations.
• Review and approve nonconformances, CAPAs and change controls.
• Review of systems release documentation (EM, water, nitrogen, processed compressed air, HVAC, WFI sanitization, CWOs, change controls, calibrations, and cleaning).
• Revise, review, and approve SOPs.
• Perform logbook reviews and verification of logbook reviews.
• Perform inspection of retain samples.
• 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, establish systems that identify opportunities for improvement and make constructive suggestions for change to improve process effectiveness to heighten quality.
• Must have 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, engineering field, or equivalent experience.
• 3+ years of experience in Pharmaceutical, Medical Device or Biotech environment writing standard operating procedures, protocols and/or reports. 
• Aseptic and injectable manufacturing experience is a plus.
• Good communication (oral, written) and interpersonal skills are necessary.

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.
• Independently investigate pharmaceutical operations and facility nonconformances, identifying any deviations from standards. This includes clearly defining problems, collecting, and organizing existing data, comparing causes to facts, identifying probable root causes, conducting interviews and SME discussions, and determining the best solutions for improvement of manufacturing processes, standard operations procedures (SOPs) and supply chain business practices.
• Collaborate with process SMEs, technical, and production personnel to understand events and occurrences. Facilitate meetings with various groups to discuss processes, participate in Kaizen events, and apply formal RCA tools to develop an investigational path for deviations.
• Independently write complex technical reports, describing investigation results and complete according to standard reporting and completion timelines for on time closure. Manage multiple priorities and deadlines independently or as part of a team to meet critical deadlines and company and departmental metrics. Conduct GMP, GDP, SOP, and awareness training as needed for deviation resolution.
• Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concept.

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:

• 3 weeks’ vacation plus floating holidays and sick leave
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your 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 their everyday performance.

COMPLIANCE OBLIGATIONS:

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:

Employee Obligations:

• Always act with honesty and integrity.
• 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:

• Always act with honesty and integrity
• 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.

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.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled