Quality Specialist

Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Assurance Change Specialist based onsite in our Tewksbury, MA facility.  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.

The Quality Assurance Change Specialist assists the Quality Assurance department by leading the various change management programs (Document, Equipment, Facility and Information Technology [IT]), all in...

We are looking for an experienced quality assurance analyst to create, collect and maintain consumer records within the Therap system ensuring all systems are updated each time a change occurs. The successful candidate should have experience with Electronic Health Records as well as have a background in Quality Assurance.

 Basic responsibilities include but are not limited to:

1.    Organizes and Maintains Therap and internal records regarding individuals receiving services.

2.    Ensures paperwork is filled out properly, verifies accuracy and accessibility of files, and is responsible for keeping files secure.

3.    Communicates with agency personnel regarding changes that occur.

4.    Creates, analyzes and distributes reports to various agency stakeholders.

5.    Answers requests for information and documents. Performs clerical tasks such as scanning,...

The primary responsibility of the Senior Quality Assurance Specialist includes supporting ATEC's quality system in compliance with ISO 13485, 21CFR820, and MDSAP. This position will support audits, ad-hoc risk assessments (including HHEs), CAPAs, Quality Planning, system process development, and occasionally support Document Control and Compliance Departments. This role supports the development and operation of the Quality Management System (QMS) at Alphatec Spine. This position also supports compliance to applicable domestic and international regulatory medical device regulations such as Part 820, 7, 806, 1271, ISO 13485, Australian Therapeutic Goods (TGA), New Zealand (Medsafe), and Japan (MHLW/PMDA).

Essential Duties and Responsibilities

• Establishes systems to assure compliance with domestic (21CFR820) and international regulations (Australia: Australian Therapeutic Goods Administration, New Zealand: Medsafe, Japan: MHLW/PMDA)
• Leads...

Responsible for the QA program and processes. Review and provide feedback to the client on the documents and deliverables ensuring that quality assurance requirements adhere to the best commercial practices and are in compliance with the applicable standards. Establish and manage quality control standards to ensure professional, accurate, complete, and timely review and delivery of System Engineering documentation.

Requirements

TS/SCI with poly required

• A Bachelor’s degree in a technical or business discipline from an accredited college or university is required.
• Four (4) additional years of experience in management, administration or quality assurance may be substituted for a bachelor's degree.
• Five (5) years’ experience in conducting quality assurance of systems and software processes on projects of similar scope, type, and complexity is required.

Benefits

Health & Life...

Navarro Research and Engineering, Inc. is recruiting a Quality Control Engineer III- Radioactive Waste Acceptance Program (RWAP)-Radiological Specialist in Las Vegas, NV.

Navarro Research & Engineering is an award-winning federal contractor dedicated to partnering with clients to advance clean energy and deliver effective solutions for complex challenges in the nuclear and environmental fields.  Joining Navarro means being a part of an exceptional team committed to quality and safety while also looking for innovative strategies to create value for the client’s success.  Headquartered in Oak Ridge, Tennessee, Navarro has active programs in place across the nation for DOE/NNSA, NASA, and the Department of Defense.

The Quality Control Engineer III – RWAP Lead in Radiological Characterization provides technical knowledge, skills, and abilities to determine if waste generators have a Nevada National Security Site (NNSS) program that is compliant with the...

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...