- Pall (Miami, FL)
- …and Preventative Actions and regulatory requirements such as ISO 9001 and AS9100. GMP , FDA knowledge and other ISO standards an advantage.Working knowledge of ... GD&T, manufacturing processes and metallurgy a plusThe salary range for this role is 155,000 - 180,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified… more
- Pall (Miami, FL)
- …understanding of ISO 9001 and AS9100 / CAA Part 145/CAA Part 21 standards. GMP , FDA knowledge and other ISO standards an advantage.Good understanding of ... applicable regulatory requirements covering Food Contact, Product Compliance (Ce Marking, ATEX, ASME etc.), Product Environmental Compliance (ROHS/REACH) and airworthiness (CAA/FAA)The salary range for this role is 155,000 - 180,000. This is the range that we… more
- Sanofi Group (Framingham, MA)
- …science, or equivalent + Experience preparing for and direct support of US FDA GMP Pre-Approval Inspections, and follow up activities (eg, inspection response ... **Job Title:** Global Quality Lead, GMP , GDP Audit and Inspection - Pipeline Launch...+ Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products… more
- Sanofi Group (Framingham, MA)
- …was possible. Ready to get started? **Main Responsibilities:** . **Ensure US FDA GMP Inspection Readiness, Inspection Activities, Inspection Follow-Up** for US ... readiness and effective response management. + Provide direct support to US FDA GMP inspections on-site to ensure successful outcomes. + In collaboration with… more
- Teleflex (Chelmsford, MA)
- …and ensure compliance with all company policies, rules, procedures, and housekeeping / GMP / FDA standards. **Education / Experience Requirements** * Minimum of ... influence people and teams at all levels. * Knowledge of ISO 13485 / FDA / GMP regulations. * Must be fluent in English. * Demonstrated record of continuous… more
- Kedrion Biopharma (Melville, NY)
- …Stamp, Access Control, Change History and Audit Trail + Conduct Data Integrity Assessments, FDA 21CFR Part11 and EU GMP Annex11 assessments + Conduct Audit ... resolve deviations, prepare final summary report) in compliance with FDA 21 CFR Part 11 and EU GMP Annex 11 regulations. + Experience in data governance, data… more
- Keurig Dr Pepper (Sacramento, CA)
- …the facility to ensure that the plant is fully operating in compliance with FSMA, FDA GMP , OSHA, EPA regulations and GFSI guidelines. + Lead the root cause ... defined by FSMA, six sigma Quality performance, and 100% compliance to all FDA , EPA and OSHA regulations. **Location:** This position is located at our Sacramento,… more
- Revlon (Oxford, NC)
- …leadership in a production environment. + Knowledge and experience with operations in a FDA - GMP environment + Significant communication skills - verbal and ... budget goals. + Coaches and trains associates to meet or exceed Quality, GMP , Safety and good Housekeeping Standards. + Must have proficient computer skills. *Backup… more
- Herbalife (Winston Salem, NC)
- …operate these lifts. **Experience:** + A minimum of 1 year of experience in FDA or GMP regulated industry **Education:** + High-school diploma (or equivalent) ... rejected, hold, etc. + Document quality-related incidents using appropriate GMP documentation (eg, nonconforming materials report, unplanned deviation report,… more
- Performance Food Group (Sioux Falls, SD)
- …you will do** + Must be willing to learn and become knowledgeable in SQF, USDA/ FDA regulations, GMP 's, Food Safety, HACCP & SOPs. + Maintain, organize and assist ... will be compliant with current regulations pertaining to SQF, USDA, HACCP, FDA , SOP's and GMP 's. + Have the ability and knowledge to read and understand… more
- Kelly Services (Jacksonville, FL)
- …non-clinical and clinical lenses. + Maintain accurate documentation to ensure adherence to GMP , FDA and ISO regulations. + Assist technical services in executing ... lenses. + Maintains lot integrity and control to ensure compliance with FDA , GMP , ISO and company requirements. + Solution Preparation and Solution testing. +… more
- PDS Tech Commercial, Inc. (Indianapolis, IN)
- …grasp of **Computer System Validation (CSV)** and regulatory compliance. + Working knowledge of ** FDA ** , ** GMP ** , and **21 CFR Part 11** regulations. + ... plus). + Supporting **automation systems** to ensure compliance with ** FDA regulations** , **21 CFR Part 11** , and... regulations** , **21 CFR Part 11** , and ** GMP ** standards. + Participating in **equipment commissioning and PQ… more
- University of Colorado (Aurora, CO)
- …complete, and submit accreditation application documentation for appropriate regulatory agencies, including FDA ( GMP and GTP), ASHI, CAP, AABB, AATB, and FACT. ... on compliance with all standards. + Assess updates to FDA regulations on human cells, tissues, and cellular and...and understanding of federal regulations on biologics including GTP, GMP , BLA, and IND. + Knowledge and understanding of… more
- Fortive Corporation (Irvine, CA)
- …PQ validation** for facility, automation, and process systems. + Ensure compliance with ** FDA , EMA, GMP , OSHA, and safety regulations** . + Support **regulatory ... operations, engineering, automation systems, and process improvements** in a ** GMP -regulated manufacturing environment** . This role ensures **compliance, efficiency,… more
- Amgen (New Albany, OH)
- …work nonstandard shifts to support 24/7 operations. + Experience in an FDA ( GMP ) or comparable regulated environment preferably Pharmaceutical and/or ... instrumentation, and control systems. + Perform required work in a GMP regulated manufacturing setting. + Implement Preventative and Corrective maintenance. +… more
- Endo International (Rochester, MI)
- …in a body of information required for the job_ _e.g. knowledge of FDA regulations, GMP /GLP/GCP, Lean Manufacturing, Six-Sigma, etc._ + Review and evaluate ... role within the Quality Control (QC) organization which oversees the GMP analytical equipment/instrumentation for both Chemical Testing and Microbiology. The… more
- System One (Piscataway, NJ)
- …RO - Reverse Osmosis, DI - Deionized Water, a big plus + Strong knowledge of FDA , EU GMP , ICH Q7, ISPE Baseline Guides, and USP requirements for facilities and ... hazard analysis) and develop mitigation strategies to maintain compliance with FDA /EU GMP regulations for pharmaceutical and biopharmaceutical operations. +… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …implement departmental operational procedures to ensure regulatory compliance within the laboratory ( FDA , GMP , ISO, CLIA, OSHA, etc.). + Make recommendations for ... Package (Excel, Word, etc.). + Must have a strong knowledge of GMP , ISO, and FDA compliance + Technical writing skills preferred + Knowledge of VITEK2 cards… more
- Abbott (Westford, MA)
- …train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA , GMP , and all other applicable agency regulations. + Ensure a ... environment. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- Abbott (Houston, TX)
- …train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA , GMP , and all other applicable agency regulations. + Ensure a ... environment. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
