Principal Specialist, Quality Assurance Operations
4 weeks ago
We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
Position Summary
Editas is seeking a cooperative, highly motivated and experienced quality professional to support internal GMP manufacturing operations. This position will be responsible for Quality Operations support of internal clinical manufacturing at the Editas Waltham and Devens GMP manufacturing facilities as a member of the Quality Operations team. Specific responsibilities include but are not limited to Quality support/oversight and leading initiatives related to: tech transfer and facility start-up, floor operations, MBR and SOP generation/revision, record review, controlled document generation, batch release, training, materials management, equipment management, and maintenance at the Editas Waltham and Editas Devens GMP manufacturing facilities.
Key Responsibilities:
As the Principal Specialist, you will be responsible for:
Support Editas’ clinical cell manufacturing facilities in Waltham, MA and Devens, MA as a member of the Quality Operations team.
Provide Quality oversight of start-up activities for a new facility and equipment as well as process commissioning & qualifications.
Review executed batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, and that all limits and specifications have been met.
Support QA on the floor activities including line clearance and QA process touchpoints as required.
Support clinical lot disposition preparation and review.
Author, review and approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing).
Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.
Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.
Independently handle complex investigations in cross-functional areas.
Exercise good judgment in issue identification and timely escalation to management.
Exercise judgment in resolving moderate to complex quality issues.
Act as QA liaison to site personnel to provide quality system expertise to help identify solutions and ensure compliance to cGMP.
Plan and execute work independently and consult with supervisor as needed.
Supports the organization in maintaining inspection readiness.
Provide QA oversight for product Shipments.
Assist in internal and external audits as required.
Requirements
Required Qualifications:
The ideal candidate will possess:
Bachelor’s/Master’s in Biology, Chemistry or other life science and 8+/6+ years respectively of relevant industry experience in Quality Assurance in a Pharmaceutical/Biotech GMP environment.
Experience supporting Quality Operations required.
A working knowledge of cGMP requirements in clinical or commercial biologics required.
Excellent verbal and written communication skills required.
Understanding of regulatory guidance on cell and gene therapy products.
Expertise working within cGMP compliance and providing GMP documentation.
Preferred Qualifications:
Additionally, candidates with the following attributes are preferred:
Experience with both early and late phase clinical manufacturing. Experience with new product introductions or facility start-ups. Experience providing quality oversight for QC.
Experience in both clinical and commercial or late stage clinical preferred.
Prior experience with mammalian cells and/or gene therapies preferred.
Demonstrated experience with mammalian cells and/or gene therapies preferred.
Experience with cell culture, single use technologies, and aseptic processing.
Experience with GMP’s in a working manufacturing environment.
Investigational skills including Root Cause Analysis and Product Impact Assessments.
Physical & Travel Requirements
Ability to gown into a cleanroom.
Ability to support a morning or evening shift schedule.
Some travel may be necessary.
Benefits
Benefits Summary:
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.
-
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Cambridge, Massachusetts, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Contract - Quality Assurance Specialist, Cmc
4 days ago
Cambridge, United States Vedanta Biosciences Full time**Title: Contract - Quality Assurance Specialist, CMC** **Location: Cambridge, MA and Acton, MA** **Reports to: Supervisor, Quality Assurance** **About Vedanta Biosciences**: **The Role**: The QA CMC Specialist is responsible for performing a wide variety of activities to ensure manufacturing compliance with applicable regulatory and CGMP requirements....
-
Director, Quality Assurance
4 weeks ago
Cambridge, United States Adaptimmune Therapeutics Plc Full timeAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Our company...
-
Cambridge, Massachusetts, United States Vedanta Biosciences Full timeTitle: Contract - Quality Assurance Specialist, CMCLocation: Cambridge, MA and Acton, MA Reports to: Supervisor, Quality AssuranceAbout Vedanta Biosciences:Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company's lead assets include potential first-in-class oral...
-
Senior Quality Operations Specialist
2 weeks ago
Cambridge, Massachusetts, United States Vertex Pharmaceuticals Full timeJob Description: General Summary: The Sr. Quality Operations Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and...
-
Quality Assurance Specialist I
4 weeks ago
Tewksbury, Massachusetts, United States Cambridge Isotope Laboratories, Inc. Full timeCambridge Isotope Laboratories (CIL) has an outstanding opportunity for a Quality Assurance Specialist I to join the team responsible for the quality of several new and existing active pharmaceutical ingredients (APIs) and medical device components based onsite in our Tewksbury, MA location. CIL is the global leading company in a highly technical,...
-
Quality Assurance Manager
2 days ago
Cambridge, United States Adaptimmune Therapeutics Plc Full timeAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...
-
Implementation and Operations Specialist
1 month ago
Cambridge, Massachusetts, United States Quality Coding Software Solutions LLC Full timeImplementation and Operations SpecialistJob DescriptionOverviewQuality Coding Software Solutions is seeking an Implementation and Operations Specialist to support our Managed Care and Community based healthcare clients. We offer an exciting opportunity to support health care insurers and providers in improving health care outcomes for vulnerable populations....
-
Senior Director, GCP Quality Assurance
2 weeks ago
Cambridge, United States Scholar Rock Full timeScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...
-
Senior Director, GCP Quality Assurance
5 days ago
Cambridge, United States Scholar Rock Full timeScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...
-
Director Quality Operations
1 week ago
Cambridge, United States EPM Scientific Full timeQuality Operations Director Key Responsibilities: Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments. Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards. Maintain and oversee a robust quality management system. Collaborate effectively with...
-
Director Quality Operations
4 days ago
Cambridge, United States EPM Scientific Full timeQuality Operations Director Do you have the skills to fill this role Read the complete details below, and make your application today. Key Responsibilities: Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments. Oversee implementation and adherence to cGMP, ICH, FDA, and ISO...
-
Director Quality Operations
1 week ago
Cambridge, United States EPM Scientific Full timeQuality Operations DirectorKey Responsibilities:Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments.Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards.Maintain and oversee a robust quality management system.Collaborate effectively with...
-
Director Quality Operations
1 week ago
Cambridge, United States EPM Scientific Full timeQuality Operations DirectorKey Responsibilities:Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments.Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards.Maintain and oversee a robust quality management system.Collaborate effectively with...
-
Quality Assurance Manager
4 weeks ago
Tyngsborough Business Park, Massachusetts, United States KLM Careers Full timeQuality Assurance Manager - MA Tyngsborough, MA Must be a US Citizen or Green Card holder The Quality Assurance Manager will be responsible for managing the quality management system and ensuring regulatory compliance for the company's products, processes, and services. RESPONSIBILITIES: Oversee the company's adherence to ...
-
Senior Supplier Quality Assurance Manager
2 weeks ago
Boston, Massachusetts, United States Talnt Full timeResponsibilities: Manage systems and processes to oversee supplier quality, including handling the supplier change control system, supplier investigations, and supplier validation activities. Oversee combination product development projects, ensuring compliance with quality standards and regulations. Manage and oversee the change control system,...
-
Cambridge, United States Apnimed Full timePOSITION SUMMARY: Make sure to apply with all the requested information, as laid out in the job overview below. The clinical quality assurance manager will provide support to ensure the quality and compliance of clinical studies conducted throughout Apnimed. This role will involve working cross functionally with internal and external stakeholders in...
-
Manager/Senior Manager, GCP Quality Assurance
2 weeks ago
Cambridge, United States Apnimed Full timePOSITION SUMMARY:The clinical quality assurance manager will provide support to ensure the quality and compliance of clinical studies conducted throughout Apnimed. This role will involve working cross functionally with internal and external stakeholders in support of CQA initiatives to ensure continuous improvement and quality in adherence to agency...
-
Manager/Senior Manager, GCP Quality Assurance
2 weeks ago
Cambridge, United States Apnimed Full timePOSITION SUMMARY: The clinical quality assurance manager will provide support to ensure the quality and compliance of clinical studies conducted throughout Apnimed. This role will involve working cross functionally with internal and external stakeholders in support of CQA initiatives to ensure continuous improvement and quality in adherence to agency...