Sr. Quality Specialist I QA/GMP Generalist
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 responsible for providing support in various areas of the Purdue Pharmaceuticals LP Quality Assurance organization including Supplier Quality Assurance, Manufacturing QA and Development QA as determined by business needs. The candidate must possess a thorough understanding, knowledge, and ability in multiple QA disciplines including 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, manufacturing site quality systems and an understanding of quality support for development projects. Conducts technical quality compliance activities in accordance with cGMP regulations, Purdue policies and Standard Operating Procedures.
- Represent QA in performing activities at the manufacturing site to include:
- Apply and implement advanced technical understanding of applicable quality systems to ensure high level of regulatory compliance and technical guidance to the company
- Assure documentation practices meet current internal SOPs and FDA Regulations
- Review and approve data to ensure compliance with GxP regulations
- Provide an in-depth knowledge of GxP regulations in other disciplines and impact on cross-functional areas
- Perform batch review/release as needed.
- Assess operational deviations and provide guidance into resolution
- Assist/Participate in corporate and regulatory audits
- Assist in compiling APR’s
- Provide Quality input into appropriateness of validation/qualification activities. Review and approval of qualification documents for accuracy, completeness, cGMP compliance, and compliance with SOPs
- Develop improvements and deliverables for QA to comply with current FDA regulations, cGMPs and company SOPs. Implement opportunities for continuous improvements and resolving potential compliance concerns with colleagues and management.
- Coordinate activities for projects to meet business timelines and deliver QA tasks on time.
- Manage relationship with third party suppliers serving as Single Point of Contact (SPOC) engaging suppliers in timely resolution of investigations, complaints, change controls, batch disposition and inspection issues and label change control review and approval; identifying and tracking to timely closure Corrective and Preventative Actions as appropriate.
- 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". May include periodic on-site visits to third party sites to observe and review operations and documentation pertinent to Purdue labeled products. Perform audits of (routine cGMP, PAI, For Cause) third party sites to compliance with FDA regulations, Purdue Specifications and adherence to the Quality Agreement
- Partner with third party to resolve technical and compliance issues. Review and approve supplier documentation. Author, negotiate and maintain Quality Agreements for third party sites.
- Manage product quality complaints in collaboration with third party site and evaluate and approve complaint investigations for thoroughness and value of CAPA items.
- Author and/or review and implement SOPs to ensure compliance with current Purdue standards and cGMP. Review and approve Annual Reports and Annual Product Reviews.
- Train Quality colleagues in processes. Provide technical understanding and direction to colleagues.
- Organize and coordinate workload and anticipate future needs.
- Maintain current knowledge base of FDA regulations in relevant technical disciplines to remain in compliance.
- Assist in any quality assurance functions as needed.
- Responsible for compliance with controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities.
- Critically evaluate data and systems and present to management with recommendations.
- Support and maintain an environment that fosters communication and teamwork within QA and related departments.
- Performs other related assignments and duties as required and assigned.
Education and Experience Requirements
Eight years (MS candidate) to ten years (BS candidate) minimum experience or equivalent level of experience in pharmaceutical or related technical operation/quality experience.
Necessary Knowledge, Skills, and Abilities
- Strong knowledge of cGMPs and experience in GMP processes and pharmaceutical document review to understand and communicate technical/documentation issues for both internal and third party CMO’s and CPO’s.
- Ability to develop good interpersonal skills and create rapport with manufacturing site and third parties
- Strong organizational skills necessary to ensure ability to manage several projects and provide appropriate follow-up.
- Ability to pivot job responsibilities as needed for the business
- Ability to react in a timely and logical manner
- Experience with external suppliers a plus. Demonstrated ability to manage relationships and appropriate use of boundaries and influence.
- Excellent written and verbal communication skills required.
- High proficiency with software applications like Excel and Word required and Trackwise or SAP a plus.
- 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 I/II, 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.
For more information about your rights under Equal Employment Opportunity, visit:
- Job Family Quality
- Pay Type Salary
- Purdue Pharmaceuticals L.P. Technical Operations, 4701 Purdue Drive, Wilson, North Carolina, United States of America