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Cerevel Therapeutics
Boston, MA, United States
Role Summary The Senior Specialist will be responsible for the processing and maintenance of the Quality System records supporting GMP activities. These records include quality events, deviations, investigations, CAPA, change controls, and complaints for R&D and Late Phase/Commercial GMP activities. This role reports to the Senior Manager, Product
Job Source: Cerevel TherapeuticsGardner Resources Consulting
Boston, MA, United States
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Job Source: DPS Group GlobalGardner Resources Consulting
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Job Source: Gardner Resources ConsultingArcaea
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Arcaea is a biology-first beauty company building a new ingredient toolset for the beauty and personal care industry. We are creating pioneering ingredients, products, and stories accessible uniquely through biology. Arcaea is building a new ingredient toolset for the beauty and personal care industry - one rooted in biotechnology with the aim of
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Job Source: ArcaeaCATALDO AMBULANCE
Danvers, MA, United States
Job Description Job Description ALS Quality Assurance (QA) Specialist Job Summary Works with each division Clinical Manager as well as the Senior Clinical Director to monitor and maintain clinical standards. Duties and Responsibilities Work collaboratively with the Clinical Director and Mangers to ensure that proper clinical standards are being
Job Source: CATALDO AMBULANCEBoston, MA, United States
Role Summary
The Senior Specialist will be responsible for the processing and maintenance of the Quality System records supporting GMP activities. These records include quality events, deviations, investigations, CAPA, change controls, and complaints for R&D and Late Phase/Commercial GMP activities. This role reports to the Senior Manager, Product Complaints & Quality Systems and supports Global Product Quality and cross-functional partners to assure robust QMS records and inspection readiness. This position will also receive, document, investigate, resolve and respond to product quality complaints and other post-market feedback.
Key Responsibilities
Maintain and review Quality Events, Deviations, Investigations, CAPAs, Change Control, and Product Quality Complaints for R&D and Late Phase/Commercial GMP activities
Review investigations to assure they are robust, properly documented (including root cause analysis, product quality impact assessment, CAPA), and adhere to procedures
Write internal/vendor Change Controls, Quality Events, Deviations, Investigations, CAPA, and Product Quality Complaints and ensure they are properly documented in Veeva and inspection ready
Maintain product quality complaint handling (documentation, coordination, investigation, resolution, closeout) and investigation processes for R&D and commercial products in compliance with regulatory requirements (21 CFR 210, 211) and internal procedures
Escalate critical complaints, quality events, trends to senior management timely, per procedure
Participate in the qualification, onboarding, and product training of call center for handling of commercial product quality complaints
Support Annual Product Reviews as they relate to Quality System records. Support any potential stock recovery/recall, and/or field alert/field correction activities, if needed
Work with internal stakeholders to establish and maintain feedback systems and other post-market surveillance processes
Participate in internal audits and health authority inspections as required for the scope of work associated with this role
Support GMP quality systems by driving regulatory compliance in accordance with applicable regulations and business objectives
Additional Quality projects and responsibilities may be assigned based on the business needs of a growing organization
Required Qualifications
At least 5 years of relevant Quality System experience in a pharmaceutical industry supporting clinical and/or commercial products
Technical writing experience; writing investigations, performing root cause analysis, and identifying CAPAs
Experience working in an electronic quality management system (Veeva or equivalent)
Understanding of GMP requirements and the drug development process
Ability to handle interactions and resolve issues with internal customers in a tactful, professional, and effective manner
Strong verbal and written communication skills to effectively communicate with cross functional business partners
Highly motivated, flexible, and able to respond quickly to shifting priorities. Able to meet deadlines, with excellent organizational skills and keen attention to details
Ability to partner and build relationships with technical operation stakeholders and external vendors to enable high quality outcomes
Ability to travel to Cerevel Headquarters in Cambridge, MA - may be up to 20%
Desired Qualifications
ASQ certification, or equivalent
Small molecule experience
Strong team player with a solutions-oriented, customer-service, and continuous improvement mind-set
Education
Bachelor's degree in life science or engineering field
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Email Alert for Senior Quality Assurance Specialist, Global Product Quality (QMS) jobs in Boston, MA, United States
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