Quality Specialist I, Documentation Systems
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!
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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 Assurance (QA) Specialist I, Documentation Systems is a position that encompasses several Quality Systems. The position conducts technical quality compliance related activities in accordance with GxP regulations and internal Standard Operating Procedures. Primary responsibilities include coordinating documentation in support of global submissions, routine document revisions, document issuance, and documentation archives.
- Ensures that documentation is maintained/archived in accordance with internal procedures and regulatory requirements (i.e. GxP, etc.).
- Compiles global regulatory submission certifications and documentation as required by business partners for ex-US submissions.
- Provides support with product and process investigations and data analysis, as requested by Quality management.
- Utilizes knowledge of regulatory requirements to identify, describe and communicate issues and participates in problem resolution and corrections.
- Issuance of documents, including but not limited to Master Batch Records, Write-up Pages, Logbooks and Lab Notebooks.
- Participates in resolving deviations associated with the Documentation Systems group.
- Participates in the management of the document period review process.
- Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
- Authors, revises and approves job related controlled documents.
- Processes documents and requests using applicable quality systems.
- Maintain current knowledge base within relevant technical discipline of FDA regulations and awareness of the necessity and impact of compliance of the business.
- Communicates and participates in identified improvements as well as mitigation of potential gaps.
- Supports regulatory inspections, as necessary.
- Performs other related assignments and duties as required and assigned.
Education and Experience:
Bachelor’s degree required and 4 years minimum relevant experience in supporting and maintaining quality systems, 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:
- Demonstrated sound understanding well developed working knowledge and ability in primary discipline.
- A thorough understanding and working knowledge of Quality Systems and tools.
- Knowledge of GxP regulations in other disciplines and awareness of impact on cross functional areas.
- The ability to recognize changes in priorities and plan as needed; to look for opportunities arising out of changing parameters.
- The ability to effectively identify and communicate challenges and their impact in a timely manner, and participate in problem resolution.
- The ability to provide guidance to personnel from a wide range of departments relative to documentation issuance, handling and archival, and MyQUMAS.
Supervisory Responsibilities (if applicable):
The incumbent reports to the Sr. Manager, Quality, Documentation Systems. The position has no direct supervisory responsibility however, the incumbent must:
- Possess the ability to independently prioritize workload.
- With minimal guidance and supervision, conducts routine and non-routine activities in the primary discipline with minimal guidance and supervision.
- With minimal guidance and supervision, plans, performs, and reports to management regarding QA and compliance activities.
- May interact with other departments/teams within the Company and with external regulatory agencies and business partners.
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
- 4701 Purdue Dr, Wilson, NC 27893, USA