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Arcaea
Boston, MA, United States
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
Job Source: ArcaeaSolutionHealth
Nashua, NH, United States
Come work at the best place to give and receive care! Job Description: Who We Are: Affiliated with Southern New Hampshire Medical Center, Foundation Medical Partners is the second largest multi-specialty group in New Hampshire and serves the greater Nashua community. We encourage the professional growth and development of our employees and are p
Job Source: SolutionHealthCambridge Isotope Laboratories, Inc.
Tewksbury, MA, United States
Cambridge 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,
Job Source: Cambridge Isotope Laboratories, Inc.CATALDO 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 AMBULANCEArcaea
Boston, MA, United States
Arcaea is building a new ingredient toolset for the beauty and personal care industry - one rooted in biotechnology with the aim of delivering radical performance and unparalleled sustainability that will also present new opportunities for storytelling. Arcaea is seeking an experienced Quality Assurance Specialist to join our team and play a criti
Job Source: ArcaeaBoston University
Boston, MA, United States
Job Description The Office of Research Compliance is in need of a Quality Assurance Officer (QAO) for the National Emerging Infectious Diseases Laboratories (NEIDL) at Boston University. The QAO will assess and monitor protocols dedicated to the development of diagnostics and medical countermeasures for diseases that require BSL-2, BSL-3, or BSL-4
Job Source: Boston UniversityBoston University
Boston, MA, United States
The Office of Research Compliance is in need of a Quality Assurance Officer (QAO) for the National Emerging Infectious Diseases Laboratories (NEIDL) at Boston University. The QAO will assess and monitor protocols dedicated to the development of diagnostics and medical countermeasures for diseases that require BSL-2, BSL-3, or BSL-4 containment. Add
Job Source: Boston UniversityKatalyst HealthCares and Life Sciences
Boston, MA, United States
Description: seeking a Quality Assurance Sr. Specialist for real time on the floor quality oversight and lot disposition of Small Molecule GMP manufacturing facility at Moderna Inc. This position will be based in our cGMP Small Molecule Manufacturing site in Cambridge, MA. The individual in this role will be part of a cohesive team responsible fo
Job Source: Katalyst HealthCares and Life SciencesBillerica, MA, United States
EPM are looking for two Quality Assurance Specialists with extensive experience in compliance responsibilities. The specialist in question will be expected to be On-Site 5 days a week, this would be a non-negotiable! The work would involve experience working with systems such as Trackwise, Veeva or QMS.
Duties and Responsibilities:
Investigates complaints to determine complaint cause, completes Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting.
Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports
Skills and Knowledge:
Bachelor’s Degree
Minimum of 2 years of experience in Quality Assurance with complaint processing role.
Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
Must demonstrate the ability to investigate complaints with minimal guidance.
Strong problem-solving skills, critical-thinker, and experienced at investigating and resolving complex issues
Understand basic principles of good technical writing skills
Excellent communication (verbal and written) and interpersonal skills required
Deep Knowledge of product quality systems Trackwise, Veeva e.g.
Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
Deep knowledge of Quality Systems (CAPA/non-conformances/SCARS)
Please send over your up to date resume and any relevant references
Kind regards,
Marcel
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Email Alert for Quality Assurance Compliance Specialist jobs in Billerica, MA, United States
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