Production Investigator/Technical Writer at Indivior in Raleigh, North Carolina

Job Description:

TITLE:
Production Investigator/Technical Writer

Title: Production Investigator/Technical Writer

Reports To: Sr. Manager Production

Location: Raleigh

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline "Focus on you" makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. 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. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category.

POSITION SUMMARY:

The Production Investigator role is responsible for investigating and reporting on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned.

ESSENTIAL FUNCTIONS:

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

This person will 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. The Production Investigator assists Operations and Quality Assurance teams to determine the disposition of non-conforming in-process product and determines if a field alert or recall is required for product that has been released.

MINIMUM QUALIFICATIONS:

• Associate degree is required; Bachelor of Science degree preferred.


• 2+ 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:

• 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.


• 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 the investigation.


• 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. Present regular updates to the Associate Director, Production.


• 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.


• Assist with revision to SOPs pertaining to component preparation, compounding, filling, and stoppering of sterile vials, lyophilizing, capping, and inspection of product based on investigation findings.


• Obtain and maintain aseptic gowning qualification.

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

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