Senior Analyst, External Testing, Quality Control 1/18/2020
Bluebird Bio Inc.
JOB DESCRIPTIONAPPLY Join bluebird bio s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek a self-starter and highly motivated experienced quality professional to manage contract testing organizations for Quality Control. This position will be responsible for managing all activities associated with release testing at CTOs and CMOs from sample submission to COA approval. The ideal candidate will have experience within biopharma QC and/or QA.
About the Role:
* 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 our 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 and external 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 CTO/CMO deviations, investigations, CAPA, and change controls.
* Support routine regulatory filings by providing lot related data
* Support process improvement initiatives across the quality department
* Provide periodic updates of QC Key Performance Indicators to management.
* BS or MS in a scientific discipline, 5+ years of related experience in QC GMP environment in a clinical and/or commercial environment
* Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders (internal and external)
* Demonstrated leadership within teams producing results
* Strong track record of interpreting cGMP/ICH/FDA/EU regulations
* Must have excellent attention to detail and the ability to manage competing priorities with aggressive timelines
* Ability to communicate above and below level in a way that fosters positive relationship building
* Superb organizational, analytical, and communications skills and do-what-it-takes attitude
* A passion for addressing the critical unmet medical needs of patients
* Self-directed individual who can work with limited direction in a risk tolerant, fast-paced, innovative environment
* Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.
bluebird bio is committed to fostering an environment where everyone can be their whole selves and know they are valued. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. As an equal opportunity employer, we do not discriminate on the basis of race, religion, color, national origin, age, gender (including pregnancy, childbirth, or related medical conditions), sex, sexual orientation, gender identity, gender expression, age, disability, veteran status, or other applicable legally protected characteristics.