Associate Manager, Quality Control - Somerville, United States - bluebird bio

Description

ABOUT THE NEST

The nest is a place where every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new gig, you become part of a flock that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:

• Persist for Purpose
• Be Compassionate
• Stay humble and curious
• Keep it real
• Celebrate (sm)all wins

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

HOW YOU'LL FLY

You'll help to bring more patients their bluebird days by:

Manage quality control-related communications within CTOs and CMOs. Coordinate testing with external laboratories and ensure adherence to release testing and scheduled product disposition timelines. Build on relationships within CTOs and CMOs ensuring issues impacting quality control testing are tracked and resolved in a timely manner. Participate and provide update on QC testing status at internal meetings. Provide data review of test records and generate Certificate of Analysis (COA). Ensure all documentation complies with cGMP regulations and industry guidelines. Generate and manage deviations, investigations, CAPA, and change controls. Support routine regulatory filings by providing lot related data. Manage external testing PO's, accruals, and invoice for the Quality Control department. Support process improvement initiatives across the quality department. Provide periodic updates of QC Key Performance Indicators to management. Position reports into Somerville, MA office; however, telecommuting from a home office is allowed.

WHAT YOU'LL BRING

You're the bird we're looking for if you have:

Requires a Bachelor's degree in Biotechnology or a directly related field plus five (5) years of experience as a Quality Control Analyst or any occupation/position/job title involving laboratory research or quality control experience.

Experience may be gained concurrently and must include:

Four (4) years in each of the following:

- Interpreting cGMP, ICH, FDA, or EU regulations

- Investigating testing issues.

Three (3) years in the following:

- Supporting inspections and generating, revising, and maintaining QC documents.

One (1) year in each of the following:

- Working in quality control GMP environment in a clinical or commercial setting

- Managing testing with CTOs.

Alternatively, will accept a Master's degree and four (4) years of described experience.

Multiple positions. Apply online:

#LI-DNI

bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.

bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.