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- ...authorizations, and agency communications, ensuring compliance with FDA, EU IVDR, and global regulations. The ideal candidate will... ...regulatory trends and implement best practices.Support regulatory inspections and audits.QualificationsBachelor’s degree in Bioengineering,...SuggestedWork at office
- ...staff endeavors to protect the public health through education and inspection of facilities that perform laboratory testing services. Various... ...testing laboratories under the Food and Drug Administration (FDA) Grade A Pasteurized Milk Ordinance of 1995, and law...SuggestedWork at office
Colorado Department of Public Health and Environment
Denver, CO7 hours agonew - ...Senior Manager, REMS Data Programmer will provide support for FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs... ...stakeholder needs. Ensure audit preparedness and support regulatory inspections for REMS. Support daily departmental tasks to meet REMS...SuggestedRemote job
- ...actively lead all aspects of Quality Engineering activities in an FDA-regulated environment and ensure compliance with cGMP and ISO 1... ...GMP facilities. Participating in quality audits and regulatory inspections as needed Mentoring and training junior level engineers...SuggestedWork experience placementFlexible hours
- ...safe work behaviors. Ensure all applicable regulatory (OSHA, FDA, DOT, EPA) requirements are met and applicable training and... ...into cylinders. Performs minor maintenance of equipment and inspection of cylinders prior to filling. Use standard pre-fill and post...SuggestedFull timeWork at officeLocal areaShift workMonday to Friday
- ...Sciences and Engineering The Office of Radiological Health (ORH) inspects facilities using radioactive by-product materials and facilities... ...authority, and delegations from, or agreements with NRC, FDA, and EPA and within established budget, and according to city, state...SuggestedFull timeWork experience placementWork at officeLocal areaWork from home2 days per week
- ...selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment... ...of DSPV process, documentation and service providers Set inspection readiness strategy for DSPV. Manage and support inspection readiness...SuggestedFull timeContract workShift work3 days per week
- ...selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment... ...and leadership team Experience in vendor audits and regulatory inspections Preferred Education and Experience: PhD in Statistics,...SuggestedFull timeContract workFor contractorsFor subcontractorWork at officeRelocationVisa sponsorshipLive inShift work
- ...selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment... ...GVP compliance and excellence Lead and/or manage and support inspection readiness and preparation activities for development organization...SuggestedFull timeContract workWork at officeShift work
- ...observe Operations and Quality Operations departments to assure that FDA current Good Manufacturing Practices, company SOPs and product... ...that require management's review and action. Conduct GMP inspections of facilities to assure compliance with the current GMP...SuggestedWork experience placementWork at office
- ...in compliance with relevant rules and regulations such as the FDA, CLIA, state testing requirements, Joint Commission, etc., managing... ...FDA reportable events, errors and deviations, performing self-inspection, and auditing, educating clinical team, reviewing and...SuggestedFull timeTemporary workWorldwide
- ...selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment... ...GVP compliance and excellence Lead and/or manage and support inspection readiness and preparation activities for development organization...SuggestedFull timeContract workFor contractorsFor subcontractorWork at officeRelocationVisa sponsorshipLive inShift work
- ...acts as the company liaison with the Health Authority (e.g., US FDA and EU EMA) for assigned projects with support, on CMC matters.... ...with PhRMA, USP, ICH, due diligence, regulatory authority inspections). Additionally, this position has direct interaction with research...SuggestedFull timeContract work
- ...Engineering The Office of Radiological Health (ORH) licenses and inspects more than 7,000 facilities using radioactive materials and x-ray... ...statutory authority, delegations from, or agreements with NRC, FDA, and NY State. DUTIES WILL INCLUDE BUT NOT BE LIMITED TO:...SuggestedWork at officeLocal areaWork from home2 days per week
- ...robust quality systems, multiple GMP certifications, and in-house FDA/EPA microbiology, quality control, chemistry, and R&D labs.... ...in manufacturing environments where the incoming materials are inspected when received. The Incoming Inspector reports to the Quality Control...SuggestedContract workShift work
- ...or State Employees: Tobacco Compliance Inspector assists the FDA in enforcing retail establishment’s compliance with the Tobacco... ...and one Youth Participant. Perform advertising and labeling inspections of tobacco retailers. Collect and document evidence of...Contract workPart timeWork at officeLocal areaImmediate startFlexible hoursWeekend work
- ...a temperature and achieve it. TherOx SSO2 Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct... ...analysis and support for incoming, in-process, and final inspection/testing. Duties include routine inspections, first article inspections...Hourly payWork experience placementWorldwide
- ...needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within... ...department procedures and work instructions are maintained; and support inspections by regulatory agencies (e.g. FDA, TUV) as requested. The...Contract workTemporary workFor contractorsWork at officeRemote workFlexible hours
- ...Quality Management Systems (QMS) in accordance with ISO 13485 and FDA 21 CFR 820 requirements as well as company protocols. Shift... ...Responsibilities: Primarily performs incoming or in-process inspection of raw materials and components for conformance to...Work at officeShift work
- ...06:00 AM – 02:30 PM Main Purpose of the role: • Performs inspection and testing of purchased materials, components, and products in... ...requirements. • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies,...Contract workFor contractorsWork experience placementShift work
- ...Rate: $17.75 DESCRIPTION/JOB SUMMARY Perform final visual and physical inspections on power wheelchairs to meet order specifications, production standards and Food and Drug Administration (FDA) regulations RESPONSIBILITIES/DUTIES • Inspect finished product for...Hourly payLocal area
- ...robust quality systems, multiple GMP certifications, and in-house FDA/EPA microbiology, quality control, chemistry, and R&D labs.... ..., tapes, labels, products compliant with written procedures. Inspects packages for defects. Works as a team to help co-workers when necessary...Contract workTemporary workWeekend workAfternoon shiftMonday to Friday
- ...Purchasers (ages 18–20) to assist in undercover tobacco compliance inspections at retail locations across North Carolina. This position plays... ...the Family Smoking Prevention and Tobacco Control Act and the FDA Tobacco Inspection Program. Age Requirement (Bona Fide...Temporary workPart timeFlexible hours
- ...products are held to the highest standards of quality, and are FDA 510(k) cleared, ISO 13485 certified, and MDSAP compliant. Argen... ...pivotal role in ensuring the quality and integrity of Argen products. Inspects works in-process and finished goods in manufacturing areas to...For contractorsWork at officeWorldwideFlexible hoursMonday to Friday
- ...implement GXP including GMP quality systems in accordance with ICH, FDA, EMA, and global competent authority regulations and industry... ..., and manage GMP batch record review and disposition. Lead inspection readiness activities for internal and external entities. Host GMP...Full timeFor contractorsWorldwide
- ...compliance with EMA Good Pharmacovigilance Practices (GVP) Modules, FDA regulations, and other international PV requirements. The role... ...the development and execution of the GVP audit program and inspection readiness initiatives. Key Responsibilities: Provide quality...Contract workFlexible hours
- ...Specialist role at Katalyst CRO A deep appreciation of Drug safety, FDA REMS program requirements and key processes. Develop and gather the material and guide the Purdue team for the future REMS Inspections. Attend and actively participate on various REMS Consortium...Contract work
$88k - $132k
...agencies, ensuring compliance with regulatory requirements such as FDA regulations and Good Manufacturing Practices. This role... ...Provides support and ensures regulatory agency responses and inspection response status updates are accurate, complete, on-point, and submitted...Full timeTemporary workWorldwideFlexible hours3 days per weekVantive
Deerfield, IL1 day ago- ...Northern California PI and research sites conducting multiple FDA-regulated or other clinical trials. Responsibilities: Compliance... ...Assist with the preparation for internal and external inspections, audits and monitor visits Assist in assuring that all site documents...Contract workWork at officeLocal areaImmediate startShift work
- ...Machinists Lab Medical Manufacturing Inc. is an ISO 13485 certified/FDA registered company that has been manufacturing orthopedic... ...blueprints/drawings. • Must exhibit a strong working knowledge of inspection equipment including comparators. • Must be self-motivated and...
