Quality Specialist III GxP Training
and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers.
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 welcome the opportunity to have you on our team!
Our Commitment to Diversity, Equity, Inclusion and Belonging
We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.
Diversity, Equity, Inclusion and Belonging are important to our business and are articulated in our People and Culture strategy and represent an important component of our goals and objectives. As we build an exciting path forward, we strive to create an environment where everyone can bring their best and true self to work each day. Embracing different backgrounds, ideas, and viewpoints are valued and encouraged. We believe that Respect is grounded in our Values of Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other. Together we make an impact on our growth, our culture, and most importantly, patients.
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)
Our Company is an Equal Employment Opportunity/Affirmative Action employer, Minority/Female/Disability/Veteran, encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, gender, national origin, religion, color, age, sex, sexual orientation, pregnancy, marital status, gender identity or expression, genetic information, disability, veteran or military status, or any other characteristic protected by local, state, or federal law.
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- Job Family Quality
- Pay Type Salary
- Purdue Pharmaceuticals L.P. Technical Operations, 4701 International Blvd. W., Wilson, North Carolina, United States of America