The Quality Assurance Manager works with other staff to establish procedures and quality standards and to monitor these against agreed upon targets. ...
Quality Engineer who, under minimal supervision, provides Quality oversight activities for the aseptic fill/finish manufacturing suite and Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes, and support systems are compliant with company guidelines and CGMP reg...
The Quality Assurance (QA) Compliance Specialist I performs compliance activities in support of production, engineering ensuring all activities are performed according to internal Quality System requirements, cGMP, FDA and ISO 13485 standards. Provide quality assurance support of investigations incl...
The Specialist, Field Quality Assurance Manufacturing, is responsible for supporting shop-floor activities in manufacturing operations at Devens in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs). Ability to understa...
Review documentation such as raw data and reports, quality control records, quality assurance records, and reports for completeness, accuracy, and compliance with methods, protocols, guidelines, and regulations and FDA regulations. Problem-solve quality issues to preserve the original timeline for v...
Must have knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements. Possesses the ability to generate and present audit/quality metrics via PowerPoint/Excel. ...
The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with counterparts in the Manufacturing, Quality Control, and Materials Management teams to help ensure high quality standards and value delivery for our patients. Senior Validation S...
The Quality Assurance Manager works with other staff to establish procedures and quality standards and to monitor these against agreed upon targets. ...
Quality Engineer who, under minimal supervision, provides Quality oversight activities for the aseptic fill/finish manufacturing suite and Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes, and support systems are compliant with company guidelines and CGMP reg...
The Principal Clinical Quality Assurance Specialist assists with internal quality assurance program for the assigned business area. Demonstrated experience in Clinical Quality Assurance and/or healthcare research compliance. Serves as clinical QA representative on clinical project teams and conducts...
Provide quality assurance support of investigations including: nonconformance and root cause analysis. Assist in the maintenance of the Quality System. Medical device quality system management experience or an acceptable combination of education and experience will be considered. ...
The Quality Assurance (QA) Compliance Specialist I performs compliance activities in support of production, engineering ensuring all activities are performed according to internal Quality System requirements, cGMP, FDA and ISO 13485 standards. Provide quality assurance support of investigations incl...
Analyze and review test packets, creating detailed test logs to track quality assurance. Oversee multiple projects concurrently, ensuring that quality standards are consistently achieved. Address quality issues promptly and develop effective solutions. Create or update procedures for capturing, inve...
The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with counterparts in the Manufacturing, Quality Control, and Materials Management teams to help ensure high quality standards and value delivery for our patients. Senior Validation S...
Quality Assurance Specialist at a Food Manufacturing Company!. Responsible for identifying quality and food safety issues & verify they have been corrected. Conduct end-product safety and quality analysis. Trainings include includes but not limit to product quality standards, GMP’s, Food Safety Issu...
The successful candidate will foster compliance across a broad range of Quality Assurance areas and will work closely with counterparts in the Manufacturing, Quality Control, and Materials Management teams to help ensure high quality standards and value delivery for our patients. Senior Validation S...
The Manager of Quality and Exit Strategy assumes the crucial responsibility of overseeing data quality and providing support to the case management team across various EA Family Shelters in North Central Massachusetts, specifically focusing on shelter exits. Additionally, the Manager of Quality and ...
The ideal candidate will have a strong background in aerospace engineering, quality assurance principles, and manufacturing processes. Regularly interface with Program Management, Engineering, Operations, and Customers to ensure understanding, documentation, flow-down, and implementation of CPI Rada...
This position is responsible for product quality analysis, disposition, and corrections. This may be done through various quality systems such as customer complaints, non-conformance reporting, and inspections. The person is this role may own quality management systems at the site which includes res...
Responsible for execution and performance of Lantheus CQA quality system elements including GCP audit programs, regulatory inspection preparation support, continuous improvement, and quality system procedural documents. Bachelor’s degree in a scientific discipline and 3 to 7 years’ exper...
Minimum of 5+ years quality assurance / technical experience in a. Supports quality and technical activities to assure Contract Manufacturing Organization (CMO) and PET Manufacturing Facilities exceed Lantheus’ requirements for Pharmaceutical Products and Positron Emission Tomography (PET) Dru...
Minimum of 7-10 years quality assurance / supplier quality engineering experience in a. Monitor supplier quality events utilizing the Lantheus Quality System, as appropriate. Plans, organizes, directs and reports on quality activities to assure external partners and suppliers meet or exceed Lantheus...
Responsible for execution and performance of Lantheus CQA quality system elements including GCP audit programs, regulatory inspection preparation support, continuous improvement, and quality system procedural documents. Bachelor's degree in a scientific discipline and 3 to 7 years' experience in the...
Responsible for execution and performance of Lantheus CQA quality system elements including GCP audit programs, regulatory inspection preparation support, continuous improvement, and quality system procedural documents. Experience in risk-based quality management systems and quality by design in Pha...
The experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below.The Client Company is in the Medical Equipment Manufacturing space and serves global healthcare and medical device companies around the world.They work with customers from co...