Specialist, Quality

MSD • Upper Gwynedd Township, PA

3d • Onsite

About The Position

The Stability Specialist will support site stability programs and be responsible for executing stability strategies and protocols for both pre-commercial and commercial stability studies. This role will facilitate stability study management, including sample receipt, sample handling, protocol creation, stability study monitoring, and all associated GMP documentation. The Stability Specialist will support cross functional teams, including our Company sites and third parties as well as domestic and international sites.

The employee will maintain clear and effective verbal and written communication with internal and external customers, participate in cross-functional teams related to stability studies, and may represent stability on site initiatives and continuous improvement projects.

Requirements

• Bachelor's degree in chemistry, Biological Science, Pharmacy, or related Science or Engineering field

Nice To Haves

• Prior experience in laboratory, technical services, manufacturing, regulatory and/or other Quality position
• Experience with vaccines, biologics, and/or devices
• Working knowledge of analytical methods, manufacturing processes, and Good Manufacturing Practice (GMP) Compliance

Responsibilities

• Manages stability studies for vaccine and pharmaceutical products, including but not limited to sample handling and receipt, sample labeling, managing sample chain of custody, protocol creation, study builds, and study closeouts
• Collaborates with partner sites and labs to coordinate sample shipment and receipt
• Reviews annual stability reviews for licensed products for accuracy
• Addresses and provides timely responses to product or project inquiries
• Maintains GMP documentation per our Company policies and procedures
• Supports deviation management for events related to stability operations or testing of stability samples. Supports implementation of corrective actions
• Responds to early warning limit excursions
• Authors or revises local Standard Operating Procedures
• Effectively utilizes applicable computer applications, including Laboratory Information Management System, Microsoft Word, Excel, and statistical software applications

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level