- Cordis (Miami Lakes, FL)
- …expansion involving cleanrooms or controlled environments + Familiarity with ISO 13485, FDA QSR, and validation protocols **Skills and Competencies:** + Advanced ... project management and strategic execution skills + Proficiency in tools such as MS Project, Smartsheet, and related planning platforms + Strong communication, stakeholder engagement, and influence skills across technical and business audiences + Ability to… more
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles ... and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities… more
- Stryker (Weston, FL)
- …internal quality system processes and ensure compliance with regulatory standards, including FDA , HIPAA, ISO, and SOC 2. **Work Flexibility:** _Hybrid_ : Candidates ... Influence new product development by defining design verification and validation test requirements to ensure compliance with design inputs...or AWS + Knowledge of SOC 2, ISO, HIPAA, FDA , or other related regulatory standards + Proficient in… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all Preventive Maintenance ... analysis to eliminate future problems. + Participates in Product Development/ Validation /Engineering project meetings to provide Quality Assurance input with respect… more
- Actalent (Tampa, FL)
- …goals. + Oversee Quality Management Systems (QMS) and ensure compliance with FDA , cGMP, and industry standards. + Manage audits, inspections, and regulatory ... submissions. + Supervise laboratory operations, including testing, validation , and equipment maintenance. + Promote a strong quality culture through training and… more
- J&J Family of Companies (Jacksonville, FL)
- …providing technical interpretation and expertise to ensure adherence to FDA /Safety/Quality policies, good engineering practices, and operation's specifications. + ... to product milestones. + Experience owning the installation, commissioning, and validation activities for automated process equipment in a regulated medical device… more
- University of Miami (Miami, FL)
- …SOPs are in compliance with relevant rules and regulations such as the FDA , CLIA, state testing requirements, Joint Commission, etc., managing FDA reportable ... to ensure efficient management of resources and workflow. + Test Method Validation : ensures testing systems provide quality laboratory services for all aspects of… more
- Teva Pharmaceuticals (Davie, FL)
- …a commercial setting. + Manufacturing and Production, technology transfer, and cGMPs, FDA , EU, and ICH guidelines Reviewing and approving Chemistry, + Manufacturing ... (CMC) content of regulatory submissions. + Participating in pre-approval inspections by FDA and other regulatory agencies. + All phases of chemical and… more
- Sumitomo Pharma (Tallahassee, FL)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
- J&J Family of Companies (Jacksonville, FL)
- …moderately complex change control projects requiring conceptual evaluation, design and validation . + Identifies, plans and executes complex change control projects ... requiring conceptual evaluation, design and validation . + Identifies, plans and executes complex qualification of...designed components. + Experience working in an ISO and FDA regulated environment. Johnson & Johnson is an Equal… more