QA Specialist (Lab Deviation Investigation)

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: The QA Specialist is a visible quality leader who improves systems and coaches/facilitates users in implementing elements of the Deviation Management System (DMS). The main objectives of this role are to monitor and elevate indicators of trends and emerging trends, to coach and align quality reviewers on consistent application of quality standards and to lead continuous improvement initiatives for process optimization and quality improvement. This position will focus on Deviation and CAPA Management elements of the QMS.

Level to be determined based on qualifications relevant to the role

Essential Duties and Responsibilities include, but are not limited to, the following:

• Position responsible for:

o Monitoring DMS performance over time using statistical methods

o Ensuring systems are fully implemented and integrated with other quality management systems

o Training system users and developing/revising training content

o Leading/facilitating system based and trend investigations identified during monitoring

o Leading/facilitating continuous improvement initiatives based on user feedback, process monitoring results, etc

• Authoring and/or reviewing investigation reports.

• Authoring and /or revising SOPs

• Identifies recurring events and ensures appropriate actions are taken, such as Management notification and trend investigation.

• Keeps QA team members informed of the status of change initiatives and manages implementation of changes throughout the IOPS organization.

• Assists as needed in audits and inspections.

• Other activities associated with tracking of projects, deviations, change controls, etc. as assigned.

Knowledge, Skills and Abilities:

• Comprehension of quality and cGMP principles, Quality Management Systems, and relevant Global regulatory guidelines.

• Experience in performing investigations.

• Experience in application of statistics to quality systems.

• Excellent written, oral, and interpersonal communication skills.

• Excellent time and project management skills with the ability to manage several tasks simultaneously.

• Ability to resolve conflict with tact and diplomacy.

• Strong attention to detail.

• Ability to arrange schedules and own activities to accomplish objectives and timelines.

• Effectively organize and manage work responsibilities under general guidance.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

• Working knowledge of Microsoft Project and/or SharePoint is a plus.

• Previous training or certification in Lean Six Sigma is a plus.

Education and Experience:

• Principal Specialist level - BS/BA degree in related field and 8+ years of industry/relevant experience.

• Senior Specialist level - BS/BA degree in related field and 5+ years of industry/relevant experience.

• Specialist level - BS/BA degree in related field and 2+ years of industry/relevant experience.

• Associate Specialist level - BS/BA degree in related field and 0-2+ years of industry/relevant experience.

• Additional experience may be considered in lieu of education.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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