Production Investigator/Technical Writer

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Production Investigator/Technical Writer

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 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 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 

The 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 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, lyophil