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PSG Global Solutions Careers
Andover, MA, United States
Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Quality Assurance - Clinical I , working in Pharmaceuticals and Medical Products industry in 1 Burtt Road, Andover, Massachusetts, United States . Performs Analytical testing on in-process, intermediate bulk
Job Source: PSG Global Solutions CareersCambridge 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.Arcaea
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: 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 AMBULANCEArcaea
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: ArcaeaHillevax
Boston, MA, United States
Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications. HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the preventio
Job Source: HillevaxDeciphera Pharmaceuticals, Inc
Waltham, MA, United States
Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled by our propr
Job Source: Deciphera Pharmaceuticals, IncDeciphera Pharmaceuticals
Waltham, MA, United States
Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Job Source: Deciphera PharmaceuticalsBurlington, MA, United States
Reports to: Sr. Manager of Regulatory Affairs
Position Summary
As our Clinical Quality Assurance Specialist, you will be a champion for Good Clinical Practices (GCP) compliance across our medical device development programs. You will ensure adherence to ICH requirements, manage clinical vendor selection and oversight, oversee clinical Standard Operating Procedures (SOPs), and lead Trial Master File (TMF) assessments. Additionally, you will play a key role in preparing for Bioresearch Monitoring ( BiMO ) audits and maintaining robust data management processes.
Primary Responsibilities
Ensure compliance with GCP principles and ICH guidelines throughout the clinical development lifecycle for medical devices.
Develop, implement, and manage a comprehensive GCP training program for internal and external stakeholders.
Lead the selection and qualification of clinical trial vendors (CROs, sites, etc.).
Develop, review, and maintain clinical SOPs to ensure alignment with GCP and regulatory requirements.
Conduct on-site audits for clinical study vendors and participating sites .
Conduct regular TMF assessments to ensure completeness, accuracy, and traceability of clinical trial documentation.
Develop and implement a quality management system for BiMO audit readiness, including risk assessments, mock audits, and gap analysis.
Analyze audit findings, identify root causes of non-conformances, and develop corrective and preventive actions (CAPAs) for GCP deviations.
Stay up-to-date on evolving GCP regulations and industry best practices.
T imely documentation of activities and maintaining all required applicable training.
Education or Certification Requirements
Bachelor's degree in a science field (e.g., biology, engineering) and/ or graduate degree in a related field.
Certified Clinical Research Professional (CCRP) or equivalent certification is required .
Certified auditor or equivalent experience in vendor assessments is a strong plus
Professional Work Experience
Bachelor's and a minimum of 5 years of experience in clinical quality assurance or a related field, with a strong focus on GCP compliance.
OR Master's and a minimum of 3 years of experience i n clinical quality assurance or a related field, with a strong focus on GCP compliance.
Qualifications and Skills
In-depth knowledge of regulatory requirements and standards for medical device clinical trials (e.g., FDA regulations , GCP principles , ICH guidelines ) .
Experience with clinical trial vendor management and oversight.
Proven ability to develop, implement, and manage clinical SOPs.
Expertise in TMF management and regulatory requirements.
Proven e xperience with BiMO audits and regulatory inspections.
Strong understanding of data management best practices for clinical trials.
Excellent analytical, problem-solving, and critical thinking skills.
Outstanding communication, interpersonal, and organizational skills.
Excellent computer skills and the ability to work with enterprise platforms, EDC, PLM, CRM, etc.
Other Essentials and Key Success Factors
Successful track record of working in high-growth and dynamic organizations .
Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit .
Ability to lead fast-paced projects with a keen sense of urgency to get the job done well .
Evidence of "hands-on" experience and expertise .
Proven and successful track record as a team-player and collaborator in small working environments .
Highly organized and detail oriented with a passion to deliver quality results .
Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation .
Highest levels of professionalism, confidence, personal values and ethical standards .
Travel
This position requires 10 % - 25 % travel.
The description and requirements outlined above are general ; additional requirements may apply.
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Email Alert for Clinical Quality Assurance Specialist jobs in Burlington, MA, United States
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