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We are seeking a Contractor Field QA Specialist for the QA Operations organization at the Single Use Facility (SUF) in Devens, MA. The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance wit
Posted 1 day ago
The Manufacturing Science &Technology (MS&T) Process Microbiology group is looking for an engaged, organized self driven individual interested in performing microbiology laboratory techniques and studying the microbial growth characteristics of microorganisms to support biologics manufacturing process. The successful candidate will work effectively across teams from multi
Posted 2 days ago
Provide administrative support to enrollment activities (form creation, archival, tracking, etc) Draft stability requirement documentation and support management of enrollments as required. Enrollment forms initiate GMP forms, and help ensure completion, review, and approval by contributing functions. Escalate information regarding impact to stability program promptly. Su
Posted 2 days ago
Sr. Lab Specialist Category Life Science Employment Type Contract Reference BH 354895 Sr. Lab Specialist Cambridge, MA 12 18 month contract $38 $41/hr We are seeking a self motivated, detail orientated, and collaborative team member to partner effectively with research staff and support day to day laboratory operations in Cambridge, MA. Core responsibilities include ensur
Posted 2 days ago
Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as ViCell, SoloVPE, Cary60, and Spectramax plate readers throughout the site which include laboratory and manufacturing buildings. Lead or provide supporti
Posted 2 days ago
We are seeking a Contractor Field QA Specialist for the QA Operations organization at the Single Use Facility (SUF) in Devens, MA. The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance wit
Posted 3 days ago
Manufacture and assemble medical device prototypes in an ISO 7/8 Environment, ensuring compliance with applicable standards. Supervise a team of 2 4 technicians focused on prototyping and production of design concepts. Work with Senior Manager to plan and coordinate daily tasks for technicians and activities of all prototyping operations with an ability to adapt to changi
Posted 3 days ago
Utilizes data analytics skills and tools to analyze vertex data systems and procedures. The individual will support developing and delivering integrated, cross modality, and cross GxP metrics and analysis that support quality governance, operational QA management oversight, and other Quality related functions. Details Power BI Data Visualization Quality Management Systems
Posted 3 days ago
Accessing large manufacturing equipment Gowning Exposure to chemicals Exposure to confined space Ability to work at different heights Work is in a state of the art large scale cell culture facility with classified areas requiring (PPE). These roles require some contact with hazardous materials such as caustic, and steam. Requires overtime, weekend, and on call duty. Decis
Posted 3 days ago
Inspector 1, Quality Control Category Manufacturing & Production Employment Type Contract Reference BH 354865 Quality Control Inspector needed for a 7 month contract to possible hire role located in Andover, MA. This position is for a global medical technology company focused on improving the lives of people living with diabetes. They have leveraged deep expertise and adv
Posted 3 days ago
Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with company policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks,
Posted 3 days ago
Drive projects in the growing Concentric lab network both domestically and internationally and covering new testing modalities such as wastewater, air monitoring, sequencing, etc. Support and advise the team in responding to complex lab issues Collaborate cross functionally to support Concentric program needs in the delivery of lab services Interface with lab partners, fu
Posted 5 days ago
include but are not limited to The mRNA Pilot Plant Team Lead supports the Process Development group in Waltham, MA, and reports to Yoh Management. We are seeking an individual to lead an mRNA GPH&TT team with pilot scale manufacturing skills and experience. Working hands on to produce large scale mRNA and LNP batches. Leading and completing large scale buffer preparation.
Posted 5 days ago
include but are not limited to Work closely with Scientists to develop a template for protocols & development study reports. Fill in report data/details and report narrative with support from scientists. Author sections in IND submissions using an established template. Thorough knowledge of IND writing is not required. Write routine laboratory SOPs and procedures with the
Posted 5 days ago
Experience in QC operation including deviation, OOS/OOT investigation, validation, tech transfer, CAPA, CCR etc and CRO/CTL management experience. Manage analytical testing outsourced to multiple CROs /CMOs. Collaborate with internal and external teams to set priorities, plan activities, monitor progress, make decisions, resolve issues, and identify risks and mitigation p
Posted 5 days ago
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