- System One (Durham, NC)
- Job Title: QA Consultant (GCP Compliance ) Location: Remote with potential travel to company sites as needed. Hours/Schedule: 20hrs/wk for first few months, then ... to assist a biotech company in preparing for an FDA audit with a strong focus on Good Clinical...with a strong focus on Good Clinical Practice (GCP) compliance . The ideal candidate will have a deep understanding… more
- Texas State University (San Marcos, TX)
- …for assistance and guidance from jurisdictions throughout the nation. The role of the FDA Tobacco Compliance Contract Specialist is to assist in the overall ... administration, coordination, training, and monitoring of the FDA Tobacco Compliance Check Program in Texas. The Contract Specialist creates and revises training… more
- Texas State University (San Marcos, TX)
- …to coordinate and provide oversight to the Food and Drug Administration ( FDA ) State Tobacco Compliance Check Inspection Program enforcement activities ... Program Coordinator and will assist the Program Manager ( FDA State Program Coordinator) in ensuring compliance ...+ Conducts ongoing technical assistance and performance monitoring of FDA Inspectors for programmatic quality assurance +… more
- MD Anderson Cancer Center (Houston, TX)
- …and the public. This position will be responsible for the regulatory and quality oversight of MD Anderson's FDA regulated investigational products and ... strong working relationship with the FDA . Effectively addresses and resolves FDA questions and concerns, ensuring compliance and alignment with Institutions… more
- Keurig Dr Pepper (Frisco, TX)
- …food/beverage products as defined by FSMA, six sigma Quality performance and compliance to all FDA , EPA and OSHA regulations and GFSI requirements. Expect ... a strong CAPA/RCCM/RCCA program that drives site improvement in Quality and Regulatory Compliance . + Regularly audit...Regional facilities to ensure they are fully operating in compliance with KDP Policy & Procedures, FSMA, FDA… more
- Kelly Services (Lodi, CA)
- …consideration, please apply. Kelly(R) Science & Clinical is seeking a Quality Assurance Specialist I for temporary position (with potential to extend/convert) ... Hiring Experts. **Pay Rate:** Night Shift: $29.37/Hour (non-negotiable) **Overview:** The Quality Assurance Specialist is responsible for reviewing records to comply… more
- Stryker (Portage, MI)
- …market feedback and customer input to improve safety and effectiveness. + Monitor compliance with Medical Quality Procedures, FDA , and other global ... more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) Stryker is hiring a ** Quality Assurance Engineer (Hybrid)** , in **Portage, MI** to… more
- Medtronic (Los Angeles, CA)
- …Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and ... device products. Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements...+ Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and… more
- Stryker (Flower Mound, TX)
- …**Regulatory Compliance and Quality Assurance** **Ensure product compliance with FDA and international regulatory standards, maintaining high- quality ... for one of Stryker's fastest-growing business units. This position will lead quality initiatives, driving continuous improvements and managing compliance with… more
- Catalent Pharma Solutions (Harmans, MD)
- …in data review, 21 CFR Part 11 instrumentation compliance . + Knowledgeable in Quality Management Systems ( FDA or ICH approach to risk management and QMS). ... The **Senior Manager, Quality Assurance Data Integrity Compliance ** performs evaluation of internal controls, communications, risk assessments and maintenance of… more
- Tecomet (Lansing, MI)
- …improve quality programs while reducing quality costs and maintaining compliance within FDA and ISO regulations. This is accomplished by utilizing ... ** Quality Assurance Manager** **JOB SUMMARY:** The Quality...+ ASQ, CQE, CQA, and/or CQM + Knowledge of ISO/ FDA Requirements **Working Conditions/Physical Abilities:** + Well lighted, heated/or… more
- Stryker (Redmond, WA)
- …testing, when required, to address post-market issues + Monitor compliance to Quality Procedures and FDA Quality System Regulations (QSR's) and update ... internships. This intern role is responsible for continuous product and process quality improvements. You will conduct investigations (potentially in the form of… more
- Stryker (Redmond, WA)
- …testing, when required, to address post-market issues + Monitor compliance to Quality Procedures and FDA Quality System Regulations (QSR's) and update ... to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) **Staff Post-Market Quality Engineer - Hybrid** Stryker is hiring a **Staff… more
- System One (Somerset, NJ)
- …years of experience working in the pharmaceutical industry in Quality /Regulatory Compliance , Requirement: * Knowledge of US FDA regulatory requirements as it ... at least 5+ years of experience working in the pharmaceutical industry in Quality /Regulatory Compliance , Quality Assurance, Quality Management Systems… more
- ePac Flexible Packaging (Los Angeles, CA)
- …of industry good manufacturing practices and standards, quality management systems and compliance to FDA requirements. + A solid knowledge of polymers and ... the Director of Operations, and a dotted line to our Manager, Quality Systems and Compliance . This role offers a competitive salary based on experience starting… more
- Tecomet (Kenosha, WI)
- …monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations for + $40 million in annual ... **Sr. Quality Assurance & Regulatory Affairs Manager** **POSITION SUMMARY**...without compromise. + Assure Tecomet is conducting business within compliance to the regulations, as cost effectively and efficiently… more
- Tecomet (Warsaw, IN)
- …monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations for + $500 million in annual ... **TITLE** : Director Quality Assurance & Reg. Affairs Systems - Worldwide...compromise. + Assure Tecomet Medical is conducting business within compliance to the regulations, as cost effectively and efficiently… more
- Teva Pharmaceuticals (West Chester, PA)
- …validation experience in pharmaceutical industry; knowledge in validation and quality compliance (cGMP/cGLP/ICH/ FDA /USP/EU policies/guidelines) * Minimum ... projects o Responsible for completing projects to meet business needs with compliance against Teva procedures and regulatory requirements o Support all aspects of… more
- Church & Dwight Co., Inc. (Fort Collins, CO)
- …This position, based in Fort Collins, CO leads the Water Pik organization to achieve compliance to the FDA Quality System Regulation (QSR), ISO 13485, MDSAP ... to Win. Role Summary Reporting to the Senior Manager Quality & Compliance - Country Business &... system procedures. Leads in procedure development eg ISO, FDA , MDSAP, when required. Ensures product quality … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …assessments as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas ... Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance . Performs routine assignments independently; supports and… more