Production Investigator/Technical Writer

We need to output HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Remove boilerplate like EEO, legal, etc. Also remove application instructions. Keep substantive info. We need to parse the posting. Title: Production Investigator/Technical Writer Who We Are: description of Indivior. That's about the company; could be "About the role"? Actually "Who We Are" is about company. Could be placed under "About the role"? The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have sections like About the role (maybe includes company overview and position overview). Responsibilities: from "How You’ll Make An Impact" bullet list. Requirements: maybe "What You’ll Bring" minimum qualifications. Qualifications: maybe additional qualifications? Actually "What You’ll Bring" includes minimum and preferred qualifications plus additional demonstration items. Could split into Requirements (minimum) and Qualifications (preferred/additional). Skills: maybe communication skills etc. Benefits: from "How We Invest In Our People". Pay: not mentioned. Schedule: not mentioned. So we should not include Pay or Schedule sections because no specific content. We must not create sections with filler like "not specified". So omit Pay and Schedule. We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep details like bullet points. We need to use

• for any list of duties/requirements/benefits, and

  for prose. We need to output only HTML fragment, no /, no markdown fences. Let's extract sections. About the role: Could combine "Who We Are" and "Position Overview". Provide prose. Responsibilities: bullet list from "How You’ll Make An Impact". Also maybe some responsibilities from "Position Overview"? Actually Position Overview describes responsibilities too. But we can include all responsibilities under Responsibilities. Requirements: Minimum qualifications: Associate Degree required; Bachelor of Science preferred; Minimum two years experience in Pharma/Med Device/Biotech writing SOPs, protocols, reports; Aseptic and injectable manufacturing experience a plus; Good communication (oral, written) and interpersonal skills required. Qualifications: Additional demonstration items: independently investigate..., review supporting documentation, collaborate..., present updates..., write complex technical reports, manage priorities, conduct training, assist with revision to SOPs, obtain and maintain aseptic gowning qualification. Skills: maybe communication skills already covered; but we could have a Skills section for "Good communication (oral, written) and interpersonal skills". However that is already in Requirements. Could still have Skills separate but might duplicate. Better to put communication skills under Skills. But we need to avoid duplication? The instruction: preserve ALL substantive information; do not invent or summarize away detail. Duplication is okay if it's in original? But we should not repeat same content unnecessarily? Not prohibited. However we can keep it under Skills and not repeat in Requirements. But Requirements already includes Good communication... required. If we move it to Skills, we might lose it from Requirements. Better to keep it in Requirements and also maybe not have Skills section if no other skills. But we could still have Skills section for "Good communication (oral, written) and interpersonal skills". However that would duplicate. Might be okay but maybe better to avoid duplication. Since we have a Skills heading, we can list skills like "Investigative root cause analysis", "Document authoring", "Training delivery", "CAPA management", "Aseptic gowning". Those are from qualifications. But those are more like qualifications/abilities. Could treat them as Skills. However the instruction says use headings as examples; we can choose which sections to include based on content. We have content for Responsibilities, Requirements (minimum), Qualifications (preferred/additional), Benefits. Skills maybe not needed if we put communication under Requirements. But we could still have Skills for things like "Investigative", "Technical writing", "Training", "CAPA", "Aseptic gowning". However those are also in Qualifications. Might be okay to have Qualifications cover those. Let's decide: We'll have sections: About the role, Responsibilities, Requirements, Qualifications, Benefits. No Skills, Pay, Schedule. Now we need to format. About the role: combine Who We Are and Position Overview into prose paragraphs. 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." We can combine into maybe two paragraphs. Responsibilities: list from "How You’ll Make An Impact". Let's extract bullet points: - 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 We need to preserve each as

• . Requirements: Minimum qualifications: - 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. We could format as list. Qualifications: Additional demonstration items (the bullet list after "In addition to the minimum qualifications, the employee will demonstrate:"). Let's extract each sentence as separate bullet? They are semi-colon separated? Actually it's a paragraph with multiple sentences separated by periods. We'll break into logical items: - 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. We could split each sentence into separate
• but keep the detail. Benefits: from "How We Invest In Our People". List: - 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 We need to output as
  • . Now ensure we don't include boilerplate like EEO, etc. Now produce HTML:

    About the role

    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.

    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.

    Responsibilities

    • 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

    Requirements

    • 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

    Qualifications

    • 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, anc