Biotechnology Quality System Regulatory Specialist Jobs

Currently, there are no Biotechnology Quality System Regulatory Specialist jobs available which match this search. You may wish to explore similar job titles on the Biotech jobs page or view related jobs below.
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Primary Role: Under the direction and supervision of the Sr. Clinical Medicine Director, the Clinical Medicine Associate Director/Director is responsible for: • Participating on the Development Team as the Global Clinical Development Lead. • Providing medical and scientific support for products within the CNS therapeutic area. • Providing primary medical leadership and support to the clinical ...
Primary Role: Under the direction of the Sr. Clinical Medicine Director, the Clinical Medicine Director is responsible, with the project team, for Clinical development support including: • Providing input into the Clinical strategy (CDP) for assigned products • Drug Safety Assessments in Clinical Programs including medical monitoring, data review and or supervision of CRO medical monitors • Pr...
Ted Pella, Inc. is a worldwide leader in the microscopy supplies and instrumentation field. We are seeking an OEM Manager who is responsible for assisting the Vice President of Marketing & Sales in driving sales growth through the design, development, and implementation of specialized OEM distributer channels. This position reports to the Vice President of Marketing & Sales. Job Description · De...
JOB FUNCTION The main activities will be to collect and analyze cleaning verification swab samples and report data as required by project contracts within the Quality Control Technical Services (QCTS) department. The data will be used for release of equipment for manufacturing and may be used for submission in Regulatory packages. DUTIES AND RESPONSIBILITIES Principal Responsibilities Independ...
The purpose of the position is to develop and execute the US Diabetes therapeutic area scientific communication strategy. The Portfolio Scientific Director will be responsible for aligning Portfolio and Brand communication initiatives from Medical Affairs across multiple channels to develop a Diabetes Medical Communications "Hub" for the US Medical Affairs team. This position aligns with the ther...
· Responsible for assessing the impact to process and product from deviations occurring during large scale biopharmaceutical manufacturing. · Uses in-depth knowledge and experience to solve complex scientific problems and to consult with customers · Performs and is able to understand and interpret all types of complex data analysis, such as multiple linear regression analysis, ANOVA and multivar...
Radius Product Development is seeking a talented and experienced Human Factors Specialist to join our Clinton, MA office. As a Human Factors Specialist, you will work closely with internal and external resources to implement human factors, research, and usability activities to drive the product development process. In this position, you will interface directly with internal team members and client...
Merck Millipore is a Life Science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. As a strategic partner, we collaborate with customers to confront the world's challenging human health issues. From research through development to production, our scientific expertise and innovative solutions help customers tackle their mos...
Requisition ID 24004BR Title Regional Clinical Research Associate (CRA)- Miami, FL Job Category Clinical Trial Management Job Description PURPOSE: Responsible for performing study activities regarding the implementation, monitoring and summarization of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs...
Biologist II The Quality Operations Laboratory Biologist I carries out live viral vaccine quality testing using manual and automated cell-based biological techniques including the classic plaque and TCID50 assays, and is responsible for daily laboratory support tasks. This entry level position plays a fundamental role in the quality release of manufactured viral vaccines for a major pharmaceutic...
GENERAL: Participate in and manage both stability and sterility activities in the stability program for PharMEDium?s services. RESPONSIBILITIES: Assist in the design and acceptance of method validation protocols preparation and execution of stability testing protocols. Manage new product evaluations based on current stability data. Identify potential areas where current stability data and lite...
The Senior Environmental Engineer will ensure compliance with environmental regulations and permits. Other responsibilities include, but are not limited to: Development, modification, and implementation of environmental permits, plans, and company procedures to ensure compliance with environmental regulations and corporate programs, procedures, policies, and manuals. Leading internal departments...
Oversees all aspects of management of laboratory operations within the different functional groups of the GMP, GCL, Vaccines & Biologics or Bio-Analytical laboratories. Ensures productivity, efficiency and quality of the work are maintained and financial objectives of the business are achieved. Oversees the development and implementation of laboratory systems and processes. Ensures client delivera...
Experis is seeking an Equipment Coordinator/Materials Associate with GMP experience. The ideal candidate will be responsible for the Capitol equipment receipts processing as well as Capitol equipment delivery logistics coordination. This is a contract opportunity located in Novato, CA. Required: Off site equipment warehouse (TransPak) coordinator Assist with equipment transport, crating and unc...
Our Company We are a rapidly growing pharmaceutical manufacturer with strong lines in hospital and ophthalmic markets, and many new products in development and awaiting FDA approval. In anticipation of long-term, substantial growth, we offer challenging, attractive career opportunities. Akorn is an Equal Opportunity Employer. M/F/V/D. The Opportunity We are looking for a temporary Quality Contr...
We are looking for laboratory technicians (animal care) for an international biotech company in Germantown, NY. near HUDSON. These positions are TEMP with a possibility of Temp to Hire for the right candidate. The positions are 40 hours / week, Monday-Friday or Sunday -Thursday PLEASE be within a commutable distance to GERMANTOWN, just south of Hudson This company is the leader in producing labo...
Description: • Provides input to the operational strategy and feasibility of clinical research studies, in partnership with development operations. • Responsible for the formulation of clinical development plans, trial design, protocols, amendments and conduct data review, analysis and interpretation. • Responsible for clinical research studies (methodology studies, biomarker studies, proof of ...
Our client, one of the most widely recognized companies in the world, is currently expanding their Medical Device division in Newport News, VA is seeking a Procedure/Technical Writer to take a role providing guidance to the business for their class II medical device division. There are 2 positions available slated for 1 year plus durations on a Contract basis. This role will be responsible writin...
QA Development Specialist The idea of being a part of a dynamic and rapidly growing organization has strong appeal for you. You're a take-charge person. You're precision-oriented and a stickler for doing it right. You have deep expertise in pharmaceutical compliance and quality control. Your critical thinking prowess makes you a problem solver extraordinaire. You generate powerful ideas and know ...
CLINICAL SPECIALIST MANAGER JOB RESPONSIBILITIES 1. Create/Manage a team of clinical specialists to become experts of Nuclear Cardiology and particularly in Cardiac PET, Lung and Endocrine disease Diagnostics 2. Create the process and manage the resources required for set-up and installation of the Rubidium Elution System (RbES) and Ruby-Fill™ generator and ensure proper troubleshooting procedu...

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