- Astellas Pharma (Northbrook, IL)
- …Represent Astellas on all statistical matters in global regulatory interactions (eg, FDA , EMA, PMDA). + Guide preparation of statistical content for regulatory ... submissions, briefing packages, and health technology assessment (HTA) dossiers. + Lead the development of statistical components of payer evidence strategies, including indirect comparisons and external control methodologies. Innovation and Methodological… more
- Cole-Parmer (Franklin, MA)
- …markets preferably in diagnostics & molecular control markets. + Understanding of FDA and international regulated markets and how such regulations impact product ... design, labeling, manufacture, and testing. + A high level of initiative, creativity, and work with little supervision. Ability to build strong executive and peer relationships. + Ability to travel up to 25%, including some international. + Willing to take… more
- US Tech Solutions (Portland, ME)
- …migration projects for in-house manufacturing software tools + Knowledge of ISO 13485 and FDA QSR. + Working knowledge of IEC 60601 and/or 62304 **About US Tech ... Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity… more
- Charles River Laboratories (Wilmington, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Lilly (Pleasant Prairie, WI)
- …or directly supporting a pharmaceutical manufacturing operation + Strong understanding of FDA guidelines and cGMP requirements + Must pass a post offer physical ... exam. + Must pass eye exam and not be color blind. + Must be able to work in shift structure **Additional Skills/Preferences:** + Bachelor's Degree in a life science, engineering, or technical field + Excellent interpersonal, written and oral communication… more
- Actalent (Madison, WI)
- …Experience in quality assurance within a regulated industry. + Familiarity with GMP, FDA , and ISO standards. + Proficiency in batch record review, document control, ... and CAPA. + Ability to conduct audits within the pharmaceutical sector. Additional Skills & Qualifications + Bachelor's degree in any science discipline preferred. + For Specialist: Minimum of 2+ years of experience in a regulated industry. + For Sr.: Minimum… more
- Boehringer Ingelheim (Dayton, OH)
- …Performs all Company business in accordance with all regulations (eg, EEO, FDA , etc.) and Company policy and procedures. + Immediately reports noted/observed ... violations to management. + Manages an assigned territory. + Responsible for the sales and marketing objectives for the assigned territory under the direction of the TBM/Sr.TBM. + Works effectively with all customer-facing roles (ie, Account teams, Medical… more
- Imperative Care (Campbell, CA)
- …catheters, endovascular or neurological devices. + Working knowledge about quality system requirements ( FDA 21 CFR Part 820 and/or ISO 13485), as they relate to ... quality control processes and good manufacturing practices. + Strong communications skills (written and verbal). + Strong ability to perform multiple tasks concurrently with high level of accuracy. + Proficiency with Microsoft Office products. Employee… more
- ManpowerGroup (Vadnais Heights, MN)
- …PQ validation activities. + Working knowledge of ISO 13485 and applicable FDA quality system requirements. + Experience supporting customer audits and quality ... discussions. + Strong root cause analysis and corrective action experience. + Ability to manage multiple projects concurrently. + Strong understanding of print reading, cGMP/cGDP, GD&T, and cosmetic specifications. + Experience with Epicor or similar ERP… more
- Abbott (Abbott Park, IL)
- …in Computer Science, IT, MIS, or related field. + Experience in FDA -regulated environments. + Familiarity with risk-based planning and project management best ... practices. + Strong vendor management and stakeholder engagement skills. **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com Follow your career aspirations to… more
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