Sr. QA Specialist II Batch Disposition

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Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications 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 conducts technical quality compliance related activities in accordance with GMP regulations and internal SOP’s. The primary responsibility is to assure compliance to cGMPs, Purdue policies, standard operating procedures, and FDA requirements.

The Senior Quality Specialist II is responsible for dispositioning raw materials, components, and batches. The scope of these responsibilities includes products manufactured by Purdue, Rhodes and 3rd parties. The Senior Quality Specialist II is also responsible for Quality Assurance activities and GMP compliance relating to equipment validation/qualification in support of manufacturing, packaging, and testing of commercial drug products. The Senior Quality Specialist II will also have responsibilities related to QA oversight of the QC Laboratory.

• Review batch documentation and laboratory analysis reports supporting the release of intermediate, bulk, and finished commercial/clinical product. Review documentation and laboratory analysis reports supporting release of commercial raw materials/components. As a result of this review, this position is responsible for making a recommendation based upon such review, for the approval/rejection of the manufactured finished product and/or raw material/component lots for commercial / clinical distribution and/or use.
• Assure proper documentation practices of validation / qualification activities meet current internal SOPs and FDA Regulations during processing.
• Review and approve deviations and investigations for qualification and laboratory activities ensuring appropriate product impact assessment.
• Performing laboratory inspections and data integrity audits.
• Assist/Participate in corporate, regulatory, and internal audits.
• Lead in preparing/revising procedures primarily related to areas of responsibilities to comply with current FDA regulations, cGMPs and alignment of company Standard Operating Procedures.
• Identify improvements for areas of responsibility as well as other Quality System processes to enhance compliance with current FDA regulations, cGMPs and company SOPs while improving…