Quality Compliance Specialist, growing Quality group
Company Name:
bluebird bio
Growing Quality group in gene therapy company
bluebird bio is developing potentially transformative, one-time gene therapies for severe genetic and orphan diseases. At the heart of bluebird bio's product creation efforts is its broadly applicable gene therapy platform for the development of new treatments for diseases with few or no clinical options. bluebird bio has two clinical stage product candidates in development, one for childhood cerebral adrenoleukodystrophy (CCALD) and one for beta-thalassemia major/sickle cell disease, and an early stage oncology program in partnership with Celgene Corporation.
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek a QA Senior Specialist to assist and support the organization with compliance and ongoing monitoring of conformance to established quality assurance processes and standards. You will support project activities, change control, validation, training, deviations, investigations, and other quality systems relating to internal and external manufacturing and testing.
About the
position
:
Perform routine reviews on manufacturing batch production record in support of product release in accordance with specifications and SOPs; generate disposition documentation
Monitor various stages of processing along with the appropriate documentation in compliance with specifications
Assure documentation is in compliance with cGMP regulations and other industry guidelines
Work closely with manufacturing and CMOs/CTOs as applicable for successful resolution of deviations, investigations, CAPAs, Change Controls, etc.
Provide QA support for regulatory filings
Assist in the day-to-day Quality Assurance operations
Support efforts to continuously improve bluebird bio's quality system management and change processes, which will lead to improved compliance and greater efficiency
Minimal travel
About you:
Bachelor's Degree and 3
years GMP experience in pharma/biotech company, working within a quality system within a regulated GMP environment
Must have a working knowledge of cGMP/ICH/FDA regulations
Experience with contract manufacturing and contract testing organizations is a plus.
Must be able to work collaboratively with cross-functional groups to ensure compliance and adherence to regulations and established procedures
Excellent organizational skills with a do-what-it-takes attitude
Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
Independently motivated, detail oriented and good problem solving ability
Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
Excellent communication skills and ability to influence across multiple functions
Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular. bluebird bio is a publicly traded company on the NASDAQ Global Select Market and trades under the symbol BLUE. We were named to the 2012 FierceBiotech Fierce 15. We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.
bluebird bio, 150 Second Street, Cambridge, MA 02141; www.bluebirdbio.com
bluebird bio will only accept
job
applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.
Estimated Salary: $20 to $28 per hour based on qualifications.
bluebird bio
Growing Quality group in gene therapy company
bluebird bio is developing potentially transformative, one-time gene therapies for severe genetic and orphan diseases. At the heart of bluebird bio's product creation efforts is its broadly applicable gene therapy platform for the development of new treatments for diseases with few or no clinical options. bluebird bio has two clinical stage product candidates in development, one for childhood cerebral adrenoleukodystrophy (CCALD) and one for beta-thalassemia major/sickle cell disease, and an early stage oncology program in partnership with Celgene Corporation.
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek a QA Senior Specialist to assist and support the organization with compliance and ongoing monitoring of conformance to established quality assurance processes and standards. You will support project activities, change control, validation, training, deviations, investigations, and other quality systems relating to internal and external manufacturing and testing.
About the
position
:
Perform routine reviews on manufacturing batch production record in support of product release in accordance with specifications and SOPs; generate disposition documentation
Monitor various stages of processing along with the appropriate documentation in compliance with specifications
Assure documentation is in compliance with cGMP regulations and other industry guidelines
Work closely with manufacturing and CMOs/CTOs as applicable for successful resolution of deviations, investigations, CAPAs, Change Controls, etc.
Provide QA support for regulatory filings
Assist in the day-to-day Quality Assurance operations
Support efforts to continuously improve bluebird bio's quality system management and change processes, which will lead to improved compliance and greater efficiency
Minimal travel
About you:
Bachelor's Degree and 3
years GMP experience in pharma/biotech company, working within a quality system within a regulated GMP environment
Must have a working knowledge of cGMP/ICH/FDA regulations
Experience with contract manufacturing and contract testing organizations is a plus.
Must be able to work collaboratively with cross-functional groups to ensure compliance and adherence to regulations and established procedures
Excellent organizational skills with a do-what-it-takes attitude
Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
Independently motivated, detail oriented and good problem solving ability
Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
Excellent communication skills and ability to influence across multiple functions
Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular. bluebird bio is a publicly traded company on the NASDAQ Global Select Market and trades under the symbol BLUE. We were named to the 2012 FierceBiotech Fierce 15. We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.
bluebird bio, 150 Second Street, Cambridge, MA 02141; www.bluebirdbio.com
bluebird bio will only accept
job
applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.
Estimated Salary: $20 to $28 per hour based on qualifications.
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