Production Investigator/Technical Writer

Indivior PLC; Raleigh (NC); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Competitive PTO

Bonus program

401(k) and Profit-Sharing

Health/Dental/Vision/Life coverage

Tuition reimbursement

Job summary

Indivior is seeking a Production Investigator/Technical Writer to investigate and report deviations in manufacturing, update SOPs, and prepare batch records. The role supports quality and operations by documenting investigations and ensuring compliance in a fast-paced pharma environment.

The ideal candidate has at least an associate degree, experience in pharmaceutical writing, and strong communication skills; aseptic/manufacturing experience is a plus, with readiness to train and lead

Qualifications

• Requires an Associate Degree; BS preferred.
• Two+ years in pharmaceutical, medical device, or biotech writing.
• Good communication and interpersonal skills.

Responsibilities

• Investigate deviations from manufacturing processes.
• Create and update SOPs, work instructions, and batch records.
• Assist audits and coordinate CAPAs with QA and production.
• Train staff on new documentation updates.

Skills

Communication skills

Interpersonal skills

Attention to detail

Education

Associate degree

Bachelor of Science

Job description

Production Investigator/Technical Writer

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 Production Investigator/Technical Writer role is responsible for investigating and reporting on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned. The role is also responsible for creating new documents, updating or doing annual review of documents such as SOPs, Work Instructions, & batch records in the manufacturing area. Will also support surrounding organizations if needed.

HOW YOU’LL MAKE AN IMPACT

• Interact with multiple functional groups to understand the problem & identify root cause(s)
• Assist in identifying appropriate corrective and/or preventive actions to prevent reoccurrence
• Create new documents
• Update SOPs and work instructions
• Train organization in new documentation updates
• Implement CAPAs
• Coordinate and keep track of manufacturing CAPAs/Deviations to make sure the departments are in compliance
• Assist in audits as a representative from production, present documents and procedures. Assist Operations and Quality Assurance teams to determine the disposition of non-conforming in-process product and determine if a field alert or recall is required for product that has been released

WHAT YOU’LL BRING

Minimum of an Associate Degree required; Bachelor of Science degree preferred Minimum of two (2) years of experience in Pharmaceutical, Medical Device or Biotech environment writing standard operating procedures, protocols and/or reports required Aseptic and injectable manufacturing experience a plus Good communication (oral, written) and interpersonal skills required.

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.

HOW WE INVEST IN OUR PEOPLE

• 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

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/Disabled are 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 atwww.indivior.comor follow us at www.linkedin.com/company/Indivior.#LI-AC1 Passion. Innovation. Achievement. All are key aspects of a career with Indivior. We are a worldwide family of individuals with varying backgrounds, strengths, and weaknesses united under one common purpose – the patient. The Indivior leadership team has built a global organization of individuals connected by a thriving culture. Our unique culture is a powerful driver of our ability to retain, develop, and recruit high performing talent while serving as the foundation for current success and future growth. It is our set of “Guiding Principles” that we believe have nurtured our culture and successfully guided our decision making.

Indivior Guiding Principles

Focus on Patient Needs to Drive Decisions Believe that People’s Actions are Well Intended Seek the Wisdom of the Team Care Enough to Coach See it, Own it, Make it Happen Demonstrate Honesty and Integrity at All Times

For those who are seeking a unique growth opportunity with a company that takes entrepreneurial approaches to creating value, we invite you to join us in our purpose to continue to pioneer life-transforming treatments for patients around the world. We look forward to hearing from you.