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Sr. Deviation /Investigation Writer (Technical Operations)

Company: Purdue Pharma
Location: Wilson
Posted on: January 24, 2023

Job Description:

Sr. Deviation /Investigation Writer (Technical Operations)

4701 International Blvd, Wilson, NC 27893, USA

Req #174

Monday, December 12, 2022

Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians, and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications through internal research & development and strategic industry partnerships.

For close to two decades Purdue has engaged in many initiatives to stem prescription opioid abuse. We are committed to bringing lifesaving relief to communities and individuals suffering from substance use disorder and overdose.We are currently developing or supporting the development of two essential life-saving opioid overdose reversal medications and have the capability to manufacture others for medication assisted treatment. Providing these medicines has the potential to improve and save countless lives.

We are driven by our purpose:Compassion for patients and excellence for science inspire our pursuit of new medicines.

We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to Purdue's Values: IntegrityandCourage, underpinned byInnovation, and always inCollaborationwith each other.

At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work.We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We strive to create an environment where you can bring your best to work each day.We welcome the opportunity to have you on our team!

We respect diversity and accordingly are an equal opportunity and an affirmative action employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.

For more information about your rights under Equal Employment Opportunity, visit:

  • EEOCKnow Your Rights
  • EEOC Know Your Rights (Spanish)

  • USERRA Rights

  • Family and Medical Leave Act (FMLA)

  • Employee Polygraph Protection Act (EPPA)

  • E-Verify (English and Spanish)

  • Right to Work (English and Spanish)

  • Pay Transparency Nondiscrimination Provision (English)

  • Pay Transparency Nondiscrimination Provision (Spanish)

    We strive to make our Career opportunities website accessible to all users. If you need an accommodation to participate in the application process, please email: careers@pharma.com. This email is not for general employment inquiries or vendors; rather it is strictly for applicants who require assistance accessing our careers website.

    Job Summary

    The Senior Deviation/Investigation Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the Technical Operations (Manufacturing and Packaging) department.
    Primary Responsibilities
    • Perform investigation activities and writing deviation investigation reports for the Technical Operations (Manufacturing and Packaging) department.
    • Coordinate prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.
    • Write concise and accurate investigation reports.
    • Utilize various root cause analysis, analytical and problem-solving tools to determine root cause of GxP deviations and assist with the completion of impact analysis and identification of appropriate corrective actions to prevent recurrence.
    • Participate in determining the appropriate corrective and preventative actions (CAPAs) after the investigation process.
    • Update, author and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs.
    • Initiate Change Controls as required for Manufacturing and Packaging operations.
    • Collaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practices.
    • Responsible for compliance with Controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities.
    • Perform other related assignments and duties as required and assigned. Education and Experience
      Requires a Bachelor's degree, preferably in a scientific discipline, with a minimum of 3-5 years of experience in a pharmaceutical or related industry.

      Necessary Knowledge, Skills, and Abilities
      • Demonstrate a sound understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing/packaging processes.
      • Minimum of 3 years manufacturing or technical experience in a regulated GxP environment, oral solid dosage manufacturing/packaging preferred.
      • Experience in troubleshooting, investigation, and root-cause/analytical/problem-solving capabilities in a GxP environment.
      • Demonstrated, strong technical writing skills with the ability to read, comprehend, and communicate complex, technical events in a manner that is concise, clear and accurate.
      • Demonstrated ability to work independently and as part of a collaborative, cross-functional team.
      • Working knowledge of TrackWise or similar deviation management system. Supervisory Responsibilities (if Applicable)
        Physical and Environmental
        • Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. Additional Information

          The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.

          Other details

          Job Family

          Technical Operations

          Pay Type


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          • 4701 International Blvd, Wilson, NC 27893, USA

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