Principal Quality Assurance Reviewer

About the role

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Quality Assurance (QA) Specialist/Reviewer to support our Fill Finish facility. In this role, you will perform all compliance related tasks necessary to review and approve investigations and provide quality oversight to the implementation of robust corrective actions for supporting manufacturing operations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Required Education

Bachelor's Degree in Life Sciences, Engineering, or related field; or equivalent combination of education and experience

Position Type

Full time

Hotbed

Pharm Country, Best Places to Work

Job Details

• Independently reviews and approves:
• Investigations into non-conformances and proposed actions to prevent reoccurrences in support of manufacturing operations
• Laboratory investigations into out of specification (OOS) and out of trend (OOT) results
• Supplier corrective action requests and proposed vendor actions
• Coaches investigation team to enable preparation of investigation reports that include recommendations on investigation findings for medium/high severity non-conformances
• Analyzes and evaluates information captured through investigations, summarizes information and trends in investigation reports
• Presents quality considerations and recommendations at group meetings with multiple levels of management
• Reviews primary data sources to assure the accuracy of investigative conclusions in accordance with cGMP standards in support of investigations
• Provides quality reviews and oversight on a wide range of investigations of differing subject matter
• Maintains monitoring of production processes and quality systems data to acquire vital data in support of investigations and track efficiency of changes
• Participates in and/or leads cross-functional study teams to get results
• Captures, trends and analyzes process related data to drive consistency and timeliness
• Trains employees on investigative processes and techniques
• Captures, trends and analyzes process related data to drive consistency and timeliness
• Coordinates and/or leads cross-functional meetings with multiple departments

Qualifications

• BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
• Principal QA Specialist: 8+ years of relevant experience
• Staff QA Specialist: 10+ years of relevant experience
• Experience with sterile drug product manufacturing, fill finish and/or quality control testing

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit here.

Pay

$92,200.00 - $176,000.00 annually

Schedule

Monday-Friday, 8am-4:30pm