Sr QA Investigation Specialist

About the Role

We are seeking a Sr. QA Investigation Specialist to support our Batch Review Operations. In this role, you will be the first point of contact for receiving and processing complaint notifications from external sources. This position offers an opportunity to contribute to a fast-growing, science-driven organization that makes a meaningful difference for patients worldwide.

Responsibilities

• Independently reviews and approves investigations into non-conformances and proposed actions to prevent reoccurrences in support of manufacturing operations.
• Reviews and approves laboratory investigations into out of specification (OOS) and out of trend (OOT) results.
• Reviews and approves supplier corrective action requests and proposed vendor actions.
• 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.
• Provides quality reviews and oversight into a wide range of investigations into differing subject matters.
• Trains employees in investigative processes and techniques.
• Coordinates and/or leads cross-functional meetings with multiple departments.

Qualifications

• Requires BS/BA in Life Sciences, Engineering or related field and 5 years of relevant experience or equivalent combination of education and experience.

Location and Schedule

Location: Rensselaer, New York, United States
Work model: Monday-Friday, 8am-4:30pm

Pay

Salary Range (annually): $78,700.00 - $128,700.00