Sr. Quality Specialist III (Supplier QA)
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!
This position is primarily responsible for providing Quality Assurance oversight of the manufacturing, packaging and testing of finished pharmaceutical products that are produced for Purdue by third party contract manufacturers and packagers. The incumbent is responsible for assuring that Purdue’s products produced at external manufacturing and packaging facilities meet all federal and other applicable regulations, and Purdue Quality Standards.
- Single point of contact (SPOC) for contract manufacturers/packagers for issues relating to manufacturing, packaging and quality. Activities include investigation of process, packaging, testing and quality related issues; recommendations for corrective actions, preventative measures and final close out.
- May include periodic on-site visits to third party sites to observe and review operations and documentation pertinent to Purdue labeled products
- Maintain open lines of communication with third party suppliers. Engage contractors in resolution of investigations, complaints, change controls, batch disposition and label change control review and approval.
- Ensure both the quality and timely close out of GMP of investigations.
- Support batch disposition by assisting in resolution of any batch documentation comments, reviewing warehouse inspection reports and approving as applicable.
- Assist contract manufacturer/packager in implementing quality systems at their sites. Partner with third party to resolve technical and compliance issues.
- Perform audits of (routine cGMP, PAI, For Cause) third party sites to compliance with FDA regulations, Purdue Specifications and adherence to the Quality Agreement. Execute or support internal audits as a part of the annual internal audit program.
- Review and approve process and packaging validation, deviations, OOSs, investigations, change controls, and stability protocols as defined in related Quality Agreements •.
- Manage product quality complaints in collaboration with third party site and evaluate and approve complaint investigations for thoroughness and value of CAPA items.
- Author NDA Field Alerts
- Approve Purdue specifications as related to packaging and labeling components.
- Participate in project teams and manage QA aspects of new product introductions
- Author, negotiate and maintain Quality Agreements for third party sites
- Review the Annual Reports and the Annual Product Reviews
- Author and/or review and implement SOPs to ensure compliance with current Purdue standards and cGMP
- Maintain communication and collaboration with third party sites and Purdue internal groups such as Pharmaceutical Technology, Supply Chain and Project Management.
- Participate on cross-functional teams within the "Virtual Manufacturing Plant"
- Assist management in moving to higher level of compliance by continually decreasing non-value-added work, identifying gaps, and closing gaps Acts as back up to Associate Director
- Other duties as assigned by manager.
Education and Experience Requirements
BS required for external candidates and 10 years minimum experience, or equivalent level of experience in pharmaceutical or related industries; or MS with 8 plus years’ experience or PhD with 4-8 plus years’ experience.
Necessary Knowledge, Skills, and Abilities
- Strong knowledge of cGMPs and experience in GMP processes and pharmaceutical document review to understand and guide suppliers with technical/documentation issues. Of importance is understanding of production processes and lines, validation, stability and OOS guidance.
- Ability to develop good interpersonal skills and create rapport with third party sites
- Demonstrate ability to manage several projects simultaneously and to address unexpected results.
- Background in working with external suppliers a plus to demonstrate understanding of relationship management and appropriate use of boundaries.
- Excellent written and verbal communication skills required.
- High proficiency with software applications like Excel and Word required.
- Experience with SAP and TrackWise a plus as Purdue Quality Systems are SAP & TrackWise based.
- Multi-tasking is an essential requirement of this job and thus strong organization skills are required to ensure appropriate tracking, closure and extension of all tasks as appropriate
Supervisory Responsibilities (if Applicable)
The Senior Quality Specialist III, SQA has no direct reports.
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: email@example.com.
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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