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SolutionHealth
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: SolutionHealthArcaea
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: ArcaeaArcaea
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 AMBULANCEBrigham and Women’s Hospital
Boston, MA, United States
Job Description - CT Quality Assurance Specialist (3291089) CT Quality Assurance Specialist - ( 3291089 ) Reporting to the Assistant Clinical Director (ACD), of CT the Quality Assurance Specialist facilitates the CT Quality Assurance program and provides appropriate education to the staff which includes assessing, planning, implementing, and
Job Source: Brigham and Women’s HospitalGardner Resources Consulting
Boston, MA, United States
Our Pharma client, located in Boston, MA, is currently searching for a Senior Quality Assurance Contractor to help maintain quality systems with a focus on GMP Compliance. The Senior QA Contractor will assist with batch record review and will provide a thorough review and analysis of mission critical data focused on QMS trending and reporting and
Job Source: Gardner Resources ConsultingBrigham & Women's Hospital(BWH)
Boston, MA, United States
Reporting to the Assistant Clinical Director (ACD), of CT the Quality Assurance Specialist facilitates the CT Quality Assurance program and provides appropriate education to the staff which includes assessing, planning, implementing, and evaluating both orientation and continuing education programs to enhance the quality of patient care services.Th
Job Source: Brigham & Women's Hospital(BWH)EPM Scientific
Billerica, MA, United States
Title: Sr. Quality Assurance Specialist Location: Billerica, MA A pharmaceutical company is seeking a Sr. Quality Specialist to spearhead Quality activities related to their combination products. The Sr. QA Specialist will be responsible for all aspects of QA for medical devices manufactured on site or through third party contractors. Responsibil
Job Source: EPM ScientificTewksbury, 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, extremely fast-growing industry and is a critical supplier to several scientific and high technology markets. CIL's growing customer base spans academia, pharmaceutical, medical diagnostic and semiconductor industries enabling collaborations with Nobel laureates, industry-leading scientists, and chemists. CIL partners with leading instrument manufacturers as well pioneering research groups that have expertise in product development and drive market growth. CIL is a subsidiary of the Otsuka Pharmaceutical Group and has had consistent growth for over 40 years.
Responsibilities:
Responsible for batch record review and release of finished products
Assist as a change management coordinator (e.g. document change plans, equipment change plans, facility change plans, IT change plans)
Authoring Annual Product Review Reports, as needed
Contributor to various QA Quality Program functions when needed (e.g. Deviation, CAPA, Supplier Management, Customer Complaints, biennial review, internal/external auditing, risk management, non-conformances, product returns, raw material review and release, etc.)
Responsible for periodic reconciliation of commercial API batch depletion
Perform room/line clearances
Label review and final inspections
Create logbooks and controlled forms
Perform GMP form reconciliation
Report authoring
Support other CIL organizations, as appropriate
Perform any related work as required
Requirements
Bachelor Degree in Chemistry/Sciences or quality assurance/management; equivalent applicable industry experience may be substituted for the degree requirement
Minimum of 5-8 years of experience in a GMP setting
Experience with Quality Assurance and knowledge and/or experience in ICH Q7, ISO 13485, is preferred
Excellent interpersonal, verbal and written communication skills are required
Attention to detail, organizational skills, ability to multitask and follow tasks through to completion. Work independently and in a team environment
Work is performed primarily in an administrative office environment
Experience with Microsoft Word, Excel, PowerPoint, Teams, Access, Adobe is a plus
Experience with electronic eQMS and ERP systems preferred
Benefits
CIL and CIS offer a competitive salary and comprehensive benefits including generous paid time off, Long Term Incentives, 6% matching 401K plan and health insurance with no in-network deductible.
CIL is an EEO/Affirmative Action employer.
Learn more about us on our website: www.isotope.com
About Us:
Cambridge Isotope Laboratories, Inc. (CIL) is the world's leading producer of stable isotopes and stable isotope-labeled compounds. With approximately 750 employees and laboratories in four countries, CIL specializes in the process of labeling biochemical and organic compounds with highly enriched, stable (nonradioactive) isotopes of carbon, hydrogen, nitrogen and oxygen. Our chemists substitute common atoms (e.g., 1H, 12C, 14N, 16O) with rare, highly valued isotopes (e.g., 2H or D, 13C, 15N, 18O) so that the final product can be readily measured or traced using mass spectrometry (MS) or nuclear magnetic resonance (NMR). CIL's products are utilized in laboratories, medical, government and academic research centers and health care facilities worldwide.
We are proud that CIL products have contributed to medical advancements in cancer research, new-drug development, environmental analysis, and medical diagnostic research. In the past decade, as the fields of proteomics and metabolomics have developed as leading techniques for determining biomarkers for disease presence, progression and the monitoring of therapeutic response, CIL has worked closely with industry leaders and researchers to provide the stable isotope-labeled tools needed for improved quantitation and qualification of complex biological systems.
After decades of research, stable isotopes have found their place in an ever expanding commercial scale applications in pharmaceuticals, semiconductors, flat panel displays as well as other high technology fields specifically with deuterium oxide (D2O) and deuterium gases. Pharmaceutical companies have begun to investigate deuteration of molecules that may provide advantages over their existing nondeuterated counterparts. In addition, increasing research into the potential medical advantages of new deuterated drugs is also occurring. In high technology, deuterated organic molecules and deuterium gas are commonly used in the manufacturing of microelectronics and OLEDs, which contribute to the increased lifetime of the devices.
Learn more about us on our website: www.isotope.com
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Email Alert for Quality Assurance Specialist I jobs in Tewksbury, MA, United States
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