- Abbott (Plymouth, MN)
- …technicians + Conduct Process FMEAs and Process Validations including driving validation strategies + Improve product quality, labor efficiency, and throughput ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- Philips (Plymouth, MN)
- …support the development/update of product requirements, design verification strategies, design validation strategies and update of design trace matrices/DHF files in ... as internal quality system requirements. + Represent Philips as appropriate in FDA , notified body, internal and external audits. Mentoring of junior staff including… more
- Actalent (Minneapolis, MN)
- …+ Review and provide input on case report forms (CRFs), database validation checks, and CRF completion instructions. + Produce randomization schedules; leads ... + Preference given to candidates with working knowledge of GCP and FDA regulations, experience working in the pharmaceutical/medical device industry and working… more
- Abbott (Maple Grove, MN)
- …familiarity of the entity operations. + Complete and execute various data validation and review processes to ensure financial information is accurately captured. + ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- Actalent (Big Lake, MN)
- …and providing guidance regarding interpreting governmental regulations and ISO 13485 & FDA standards in link with the Manufacturing Quality Engineer activities. The ... as part of a cross-functional team. - Participate and be the QA lead for validation of equipment repairing with Maintenance, IT and the APU. - Interface with client… more
- Sumitomo Pharma (St. Paul, MN)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations + Advanced proficiency in BASE SAS… more
- Cytel (St. Paul, MN)
- …of CRFs, edit check specifications, data transfer specifications, and data validation plans. + Performing statistical analyses and interpreting statistical results. ... and explain the methodology and consequences of decisions. + Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes… more
- Cardinal Health (St. Paul, MN)
- …meetings as scheduled and follow up on improvement actions. + Support process validation and calibration programs and activities for the portfolio. + Manage and ... standards, principles, and techniques utilized within the Quality Assurance field + FDA regulated industry experience as well as applicable Quality System Standards… more
- ManpowerGroup (Becker, MN)
- …and providing guidance regarding interpreting governmental regulations and ISO 13485 & FDA standards in link with the Manufacturing Quality Engineer activities. The ... part of a cross-functional team. 3. Participate and be the QA lead for validation of equipment repairing with Maintenance, IT and the APU. 4. Interface with client… more
- Abbott (St. Paul, MN)
- …safety rules, manufacturing procedures, company policies and procedures, QSR and FDA regulations. + Proficient in basic assembly procedures. Build and evaluate ... the end product, successfully meet all planning based on design, testing, verification, validation for new and existing products, and support of team members. + The… more