- Intake and management of pharmaceutical product complaints reporting to ensure patient safety and that Quality Systems Event and Action (QMS) function remains compliant with domestic and international biomedical and biotechnical regulations, laws, and guidelines.
- Utilize expertise and knowledge of biotechnology and regulatory standards to support Quality Management Systems (QMS) users and actions including deviations, investigations, root cause analysis, CAPA, change controls, and product complaints;
- Partner with internal departments to verify Blueprint's eQMS process and define improvements to ensure that all internal standards and procedures meet business requirements and strategy;
- Identify revisions to Standard Operating Procedures (SOPs) and work instructions to ensure quality control and compliance standards are being met internally and externally;
- Prepare and report on QMS quality metrics to support periodic QMS reviews and Quality Council;
- Assist in the update and verification of changes to validated Veeva eQMS, QualityDocs and Training system and procedures; and
- Collaborate with Quality and other cross-functional teams to support and grow Quality culture.
- 1 year experience in pharma or medical device product complaint and/or adverse event processing providing knowledge of cGMP regulations in pharmaceutical or medical device industry to support CAPA, Deviation, and Change Control.
- 1 year working with regulated controlled documents.
- 1 years' experience in supporting regulatory inspections, including ensuring requirement documents are inspection-ready.
- 1 years' experience with using regulated computer systems (e.g. Veeva, Trackwise, Master Control, or similar).
- Commitment to our
- This position is part of Blueprint Medicines' employee referral program and is eligible for an employee referral incentive bonus.
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Specialist, Quality Systems - Cambridge, United States - Blueprint Medicines Corporation
Description
Requisition #: 24-600What will you do?
Job Duties:
Position requirements:
Master's degree in biotechnology or a closely related life science field (or foreign equivalent degree), plus 1 year of experience in a quality function in pharmaceutical and/or medical devices.
Experience, which may be gained concurrently, must include:
Core Values:
Patients First, Thoughtfulness, Urgency, Trust, Optimism
Why Blueprint?
At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators - the Blue Crew.
Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization.
We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.
This is the place where the extraordinary becomes reality, and you could be part of it.Patients are waiting. Are you ready to make the leap?
Equity, Diversity, Inclusion and Affirmative Action
At Blueprint Medicines, we foster a culture of equity, diversity and inclusion.
A proud Equal Employment Opportunity and Affirmative Action employer, we consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law.
We are also an E-Verify Employer. We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability in need of an accommodation with the application or recruiting process, please reach out to
For more information, please see our EEO-AA Policy Statement, the EEO Know Your Rights Poster, as well as our Pay Transparency Statement.
Blueprint Medicines is a fully-integrated, commercial-stage, global biopharmaceutical company that invents life-changing medicines in two core, strategic areas of allergy/inflammation and oncology/hematology.
We pursue discovery, development, and commercialization of therapies that potently and selectively target known drivers of disease, with focused investment in therapeutic areas where we can leverage our core expertise and business infrastructure to bring scale to our science.
We are bringing an approved medicine to people living with systemic mastocytosis (SM) in the U.S. and Europe, and globally advancing additional programs for mast cell-mediated diseases, including SM and chronic urticaria.Additionally, we have a pipeline of research and development programs that range from early science to advanced clinical trials in mast cell-mediated diseases, including SM and chronic urticaria, breast cancer, and other solid tumors vulnerable to CDK2 inhibition.
