Production Investigator/Technical Writer

Indivior PLC; Raleigh (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Indivior PLC is seeking a Production Investigator/Technical Writer to investigate deviations in manufacturing, prepare reports, and update essential documentation. The role also supports CAPAs, audits, and QA interactions within a fast-paced biotech environment.

Qualified candidates will have at least an Associate degree, with a BS preferred, and experience in aseptic manufacturing or documentation. Strong writing and communication skills are required for cross-functional collaboration and

Qualifications

• Minimum of an Associate Degree required; Bachelor of Science degree preferred.
• Aseptic and injectable manufacturing experience a plus.
• Good communication (oral, written) and interpersonal skills required.

Responsibilities

• Investigate deviations to manufacturing processes and report findings.
• Create and update SOPs, Work Instructions, and batch records.
• Assist in CAPAs, deviations tracking and audits; collaborate with QA and Operations.
• Present updates to the Associate Director, Production and support timely closure of investigations.

Skills

Technical writing

SOP writing

Investigation

Communication skills

Education

Associate degree

Bachelor of Science

Job description

TITLE:Production Investigator/Technical WriterWHO WE AREIndivior 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 an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.POSITION OVERVIEWThe 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 IMPACTThe responsibilities of this role include, but are not limited to, the following:Interact with multiple functional groups to understand the problem & identify root cause(s)Assist in identifying appropriate corrective and/or preventive actions to prevent reoccurrenceCreate new documentsUpdate SOPs and work instructionsTrain organization in new documentation updatesImplement CAPAsCoordinate and keep track of manufacturing CAPAs/Deviations to make sure the departments are in complianceAssist 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 releasedWHAT YOU’LL BRINGMinimum of an Associate Degree required; Bachelor of Science degree preferredMinimum of two (2) years of experience in Pharmaceutical, Medical Device or Biotech environment writing standard operating procedures, protocols and/or reports requiredAseptic and injectable manufacturing experience a plusGood 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 PEOPLEIndivior 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:Competitive PTO plus company closure from December 24th- January 1stEligible to participate in Indivior’s bonus program, based on company and individual performanceEligible to receive a yearly grant as part of Indivior’s Long-Term Incentive Plan401(k) and Profit-Sharing Plan- Company matchU.S. Employee Stock Purchase Plan- 15% DiscountComprehensive Medical, Dental, Vision, Life and Disability coverageHealth, Dependent Care and Limited Purpose Flex Spending and HSA optionsAdoption assistanceTuition reimbursementConcierge/personal assistance servicesVoluntary benefits including Legal, Pet Insurance and Critical Illness coverageWellness programs as well as other discounts and perksOUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCTIndivior is committed to maintaining a 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 pressureRisk 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 pressureReinforce 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 OPPORTUNITYEOE/Minorities/Females/Vet/Disabled are encouraged to apply!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.Want to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.#LI-AC1