Sr. Quality Specialist , Documentation Systems

Sr. Quality Specialist I, Documentation Systems

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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!

The Quality Assurance (QA) Sr. Quality Specialist, 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 conducting product complaint investigations, administration of site change control program, compiling of annual product reviews, coordinating documentation in support of global submissions, routine document revisions, document issuance, and documentation archives.

• Perform complaint investigations for Purdue manufactured products and work closely with Supplier Quality Assurance to obtain required 3rd party investigative details, as required.
• Escalate product complaints as deemed necessary for field action and prepare field alerts as applicable.
• Author and/or review and implement SOPs to ensure compliance with current Purdue standards and cGMP as related to areas of responsibility.
• Compile, review, and facilitate approval of Annual Reports and Annual Product Reviews.
• Assist with administration of site Change Control Program.
• Assist with the generation of monthly and quarterly metrics as required by SOPs and review metric reports to ensure the appropriate metrics are being captured.
• Assist with administration of the electronic documentation management system.
• Ensure that documentation is maintained/archived in accordance with internal procedures and regulatory requirements (i.e., GxP, etc.).
• Compile global regulatory submission certifications and documentation as required by business partners for ex-US submissions.
• Provide support with product and process investigations and data analysis, as requested by Quality management.
• Utilize knowledge of regulatory requirements to identify, describe, and communicate issues and participate in problem resolution and corrections.
• Issue of documents, including but not limited to Master Batch Records, Write‑up Pages, Logbooks and Lab Notebooks.
• Participate in resolving deviations associated with…