- 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
- Actalent (Hilliard, OH)
- …Skills & Qualifications + High School Diploma or GED + Prior experience in GMP , FDA , or strict SOP environments preferred + Comfortable with aseptic gowning ... Job Title: GMP Operations Technician Job Description We are seeking...pharmaceutical industry. Responsibilities + Follow SOPs, GMPs, and all FDA regulations. + Conduct component preparation, aseptic cleaning, equipment… more
- Actalent (Hilliard, OH)
- …preparation + Conduct quality checks and inspections on production lines + Follow strict GMP , SOP, and FDA guidelines + Work in cleanroom environments with full ... Looking For: + High School Diploma or GED required + Experience in GMP , FDA , or SOP-regulated environments is a plus + Comfortable wearing full cleanroom gowning… more
- Merck (Durham, NC)
- …military environment, or related industry including two (2) years of experience in an GMP or FDA regulated industry. + Bachelor of Science with minimum of ... environment, or related industry including two (2) years of experience in an GMP or FDA regulated industry. + Schedule: Monday - Friday, 2:00 PM - 10:30 PM… 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
- Herbalife (Winston Salem, NC)
- …for this position. **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
- 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
- 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
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