(US-Michigan) Our client, a major pharmaceutical company in Ann Arbor, MI is looking for a Senior Validation Specialist with the following qualifications: Requirement Notes: *This candidate must know computer system validation and different software life cycles. The candidate should have experience in retrospective validation, computer system validation experience as well as equipment validation experience. This person must know 21CFR Part 11 as well as participate in assessment and remediation of lab and drug product manufacturing systems. You MUST meet all of the above qualifications in order to be considered for this position. You MUST be either a US Citizen or a Green Card Holder in order to be eligible for this position. Unfortunately, at this time we CANNOT work with third parties or relocate anyone.
(US-Ohio) Our client is looking for a New Product Development (NPD) Systems Administrator with the following qualifications: - Expedite loading and maintenance of software tools utilized in NPD. - Roll out software tools and train on usage. - Administer web sites and software tools. - Interface with Information Management for delivery, maintenance, and troubleshooting of software tools. - Support software validation efforts. Requirements: - Detail oriented, able to compile and analyze information. - Able to program and read computer languages. Intranet/Internet site management (using HTML). - Strong written and verbal skills. - Interpersonal skills to work well with all levels/functions in the organization. - Capable of managing multiple and competing projects. - 2 yr technical degree in Information Systems or Computer Science or equivalent work experience. (4 yr degree preferred) - 3 years experience in a customer oriented work environment & 1 year working with the development of Internet sites. - Experience with CAD/CAE and PDM/PLM a big plus. - Experience with Medical Device Regulations, FDA requirements, a big plus. You MUST meet all of the above qualifications in order to be considered for this position. You MUST be either a US Citizen or a Green Card Holder in order to be eligible for this position. Unfortunately, at this time we CANNOT work with third parties or relocate anyone.
(US-Connecticut) Our client, a major pharmaceutical company in New London, CT is looking for a CE Training Support Lead with the following qualifications: Requires: Demonstrated Leadership and strong people skills; Good organizational skills; Experience with data analysis and problem solving; Experience with training programs (leading, developing, and coordinating). Preferred: Experience with vendor management, Experience building or launching an organization or business unit. Major Duties: 1) Participate as a key member of the Common Engineering training team to set strategy for global informatics training 2) Act as a registrar for global training. Support and mentor project training team and registrars 3) Manage vendor contract information. Assist training manager in developing contract relations and pricing models 4) Build and implement a communications plan for global informatics training 5) Assist with the development and tracking of performance and cost measures and metrics. 6) Support project training development teams with access to and use of training standards and templates. You MUST meet all of the above qualifications in order to be considered for this position. You MUST be either a US Citizen or a Green Card Holder in order to be eligible for this position. Unfortunately, at this time we CANNOT work with third parties or relocate anyone.
(US-Wisconsin-Madison) This individual will manufacture and quality test components/kits and support new product transfers within the product area. ESSENTIAL DUTIES: 1.Develops plans, goals, and milestones for projects in areas of responsibility. Implements experimental design, performs analysis of project specific data, and uses scientific and technical resources to recommend solutions and solve problems. Analyzes operational and cost impacts of process/product improvements. Identifies/solicits internal or external people to solve problems, supports accomplishment of project/team goals. Monitors progress of projects and leads team to meet objectives and effectively communicates team/project goals through presentations and reports. 2.Participate in multidisciplinary product improvement and development teams by providing information and technical support to meet team goals. Design experiments to problem-solve and improve existing manufacturing and QC processes. When necessary, seeks assistance to meet production planning needs, coordinates production planning in multiple product areas. 3.Independently manufacture a variety of components for the product lines so as to meet product specifications. Plans production schedules to assure on-time delivery of products. 4.Write, review and revise, as necessary, manufacturing and QC protocols for clarity, appropriate technical content, process improvements, scale-up and/or raw material changes as prescribed by the Promega Corporation Quality System. 5.Perform assays to assure that products meet existing requirements for purity, activity and functionality. Responds to customer complaints and makes recommendations for QA hold/product recall and for quality improvements.
(Switzerland) Toxicologists of all levels are required for all locations in Western Europe (Denmark, Switzerland, France, Germany) and the UK. The key skill set that is required is as follows: ·To provide toxicology and regulatory support for new product development and existing products. ·Clinical ·Collecting, analyzing and interpreting study data. ·Biochemical assays. · Using analytical equipment, HPLC, GC-MS, NMR and TLC. · Gel electrophoresis, western blotting and PCR analysis, DNA extraction, expression, isolation. ·GLP and non-GLP in house short-term in vitro and in vivo toxicological studies. ·To conduct public health assessments, including toxicological investigations and related activities to determine actual or potential human health risks from exposure to toxic substances in the environment or workplace. Background: Interested candidates are to have a Master's Degree/PhD in environmental health, risk assessment, environmental epidemiology, toxicology, biochemistry, or pharmacology. The candidate should also have experience writing public health assessment reports and related technical documents.
(UK) An experienced scientist/research associate is required to work within the discipline of stem cell research; the main duties: tissue cell culture, invitro fertilisation, FAC's analysis, Cellular assays, PCR, ELISA, GLP. Experience in clinical grade cell production facility is highly desirable.
(UK) An experienced candidate is required to work for a biotech company in the QA department , to lead other QA employees and act as the QP for small - large batch release of products . The successful candidate will obviously be working in the manufacturing department and requires someone who has been registered as a QP within European Standards.
