Senior Specialist Quality Assurance

Senior Specialist Quality Assurance Skip to main content
* This site uses cookies to provide you with an optimal user experience. The cookies include Strictly Necessary and Functional cookies to ensure the site operates as intended (language preference, time zone and workload balance). These cookies are first party cookies, end with the session and are exempted from consent. In addition, this site also uses a Google Analytics Cookie to measure and improve the performance of our site.

All information these cookies collect is aggregated and therefore anonymous. By clicking on the ‘Accept Cookies’ button, you are accepting this Performance cookie.  You may use this site if you click on the ‘Reject Cookies’ button. To revoke your consent of the Performance cookie, clear your cookies within your browser settings.*#Senior Specialist Quality Assurance page is loaded## Senior Specialist Quality Assurance Apply remote type:
Hybrid locations:
USA
- Pennsylvania
- West Pointtime type:
Full time posted on:
Posted Todaytime left to apply:
End Date:
July 10, 2026 (14 days left to apply) job requisition :
R404250
** Job Description
**** Senior Specialist, Quality Assurance:  Principal Quality Auditor
** The mission of Quality Assurance is to: safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies. This position reports to the Director, Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials.

Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc.

** Responsibilities may include, but are not limited to:
*** Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations.
* Coordinate and/or support the preparation of procedures, processes and quality improvements.
* Leading projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve outcomes, reduce cost, or lower our processing cycle times.
* Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.
* Assists in the coordination of significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions.
* Providing on-the-floor coaching/guidance of operational and technical issues; providing immediate resolution on the shop floor to deviations and potential deviations.
* Managing investigations, change requests and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.
*
* Education:

** Minimum of a Bachelor's degree with a technical emphasis in an appropriate scientific or engineering field.
** Required

Experience and Skills:

*** Minimum of 5-years’ experience in the pharmaceutical or equivalent industry Good Manufacturing Practice (GMP) related field including Technical, Regulatory, Quality or Operations.
* Familiarity with clinical supply batch disposition (release), clinical supply operations, or regulatory filing activities.
*…