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Quality Specialist III, GxP Training (Onsite)

Company: Purdue Pharma
Location: Wilson
Posted on: March 16, 2023

Job Description:

Quality Specialist III, GxP Training (Onsite)

4701 International Blvd, Wilson, NC 27893, USA

Req #171

Monday, November 21, 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 Quality Specialist III, GXP Training is required to support and enhance the quality training programs related to applicable regulatory requirements, as well as local and global processes. Primary duties include business administration of the Cornerstone on Demand (CSOD) Learning Management System, including but not limited to, review and assessment of quarterly release revisions, curricula maintenance, data entry and reporting. In addition, the position evaluates existing manufacturing training programs and data trends to identify training needs and develop new training. This evaluation assesses the adequacy of training materials and programs in a GxP environment. Position will work closely with IT, manufacturing business units and site management to streamline/progress training needs.

    Primary responsibilities:

    • Provide business administration support for the CSOD system for the Wilson site, including assessment of quarterly system releases vs. business needs.

    • Support validation testing of system changes, upgrades from an SME perspective.

    • Meet with business functions routinely to identify, recommend, and implement improvements to the training function to make it more effective and efficient in supporting business objectives and compliance requirements. This should reflect industry best practices.

    • Facilitate the development/maintenance of training curricula for the RTP and Wilson sites.

    • Perform training needs analysis and effectiveness assessments as deemed appropriate. Coordinates/delivers other regulatory training as required.

    • Ensure training documentation is accurate and compliant with Good Documentation Practices

    • Coordinate with Training colleagues at the Stamford site to develop and implement training programs to improve training effectiveness, standardize practices and optimize operations.

    • Establish and maintain industry contacts on current compliance and training issues by participation in external Training industry groups.

    • Proactively support company priority initiatives with activities that are outside planned responsibilities and objectives.

    • Maintain electronic and paper GXP training files, ensures files are current and in compliance with regulations and internal procedures.

    • Coordinate with LMS owner to provide training records as requested in support of external and internal audits.

    • Provide SME input on deviations, Laboratory Investigations, Planned Deviations, Change Controls and CAPA.

    • Provide training direction, analysis, and guidance regarding quality related compliance.

    • Perform other related assignments and duties as required and assigned.

      Education and Experience

      BS required and 4 years minimum relevant experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 2 years minimum relevant experience

      Necessary Knowledge, Skills, and Abilities

      • A thorough understanding of cGMP and excellent working knowledge of FDA regulations

      • Experience in managing curricula in Cornerstone on Demand or similar LMS

      • Preferred experience in the creation of Manufacturing/Laboratory On-boarding programs

      • Experience in establishing training effectiveness programs

      • A strong ability to resolve and communicate technical issues, and perform root cause analysis

      • Demonstrated ability to act as a functional expert and provide input as such

      • Ability to negotiate needed actions and manage difficult interactions effectively.

      • Knowledge of computerized support tools and training software

        Supervisory Responsibilities (if Applicable)

        This position has no direct reports.

        Physical and Environmental Requirements

        • Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the followingequipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting.

        • Ability to work a 10 hour per day/4-day work week; 40 hours per week with overtime as required.

          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.

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          • 4701 International Blvd, Wilson, NC 27893, USA

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Keywords: Purdue Pharma, Wilson , Quality Specialist III, GxP Training (Onsite), Other , Wilson, North Carolina

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