Quality Specialist III GxP Training
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: Integrity and Courage, underpinned by Innovation, and always in Collaboration with 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!
The Quality Specialist III, GXP Training is required to support and enhance the quality training programs related to key compliance initiatives, applicable regulatory requirements, and processes. Primary duties include administration of the Cornerstone Learning Management System, including business process configuration and testing; efficient curricula creation maintenance; data entry and assessment creation. This position evaluates existing training programs in the GxP environment and data trends to identify training needs and develop new training. Position will work closely with IT, business units and site management to streamline/progress training needs.
- Providing business administration for the Cornerstone system including configuration and testing, curricula creation and maintenance, process optimization
- Identifying, recommending, and implementing improvements to the training function to make it more effective and efficient in supporting business objectives and compliance requirements
- Perform training needs analysis and effectiveness assessments and deliver programs as deemed appropriate. Coordinates/delivers other regulatory training as required
- Ensuring training documentation is accurate and compliant with Good Documentation Practices
- Coordination with Training colleagues at all sites to develop and implement training programs to improve training effectiveness, current practices and optimize operations
- Establishing and maintaining 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 paper GXP training files, ensure current and in compliance with regulations and internal procedures
- Provide training records and reports as requested in support of external and internal audits
- Provide Quality SME input on deviations, Laboratory Investigations, Planned Deviations, Change Controls and CAPAs
- Provide training direction, analysis, and guidance regarding quality related compliance issues
Education and Experience
Quality Specialist III, GXP Training must have:
BS required for external candidates 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 administering an LMS system from a business perspective
- Experience in establishing training effectiveness programs
- A strong ability to resolve and communicate technica lissues, and perform root cause analysis
- A demonstrated ability to act as a functional expert
- Ability to negotiate needed actions and manage difficult interactions effectively
- Knowledge of computerized support tools and training software
Supervisory Responsibilities (if Applicable)
Purdue Pharma L.P. & its Subsidiaries are an Equal Opportunity (EEO) and Affirmative Action Employer encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, national origin, religion, age, sex, sexual orientation, marital status, gender identity, genetic information, disability, military, protected veteran status, or any other characteristic protected by local, state, or federal law. Protected veterans and qualified individuals with a disability may request a reasonable accommodation by emailing: firstname.lastname@example.org.
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- Job Family Quality
- Pay Type Salary
- Purdue Pharmaceuticals L.P. Technical Operations, 4701 Purdue Drive, Wilson, North Carolina, United States of America