- Cytiva (Miami, FL)
- …functions, and facilitate risk-based decisions.Prepare, update and review regulatory support documentation , including Validation Guides, statements, certificates ... the Danaher Business System which makes everything possible.The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the Business and… more
- Beckman Coulter Life Sciences (Miami, FL)
- … documentation , inclusive of Design History, Product, Process and Service documentation in support of product realization and commercialization within the ... Beckman Coulter quality system.Awareness of current industry standards and regulations and how they relate to internal policies and procedures. Influences interpretation of internal policies and procedures to ensure quality and compliance.The essential… more
- Beckman Coulter Diagnostics (Miami, FL)
- …to build a meaningful career, be creative, and try new things with the support you need to be successful.Beckman Coulter Diagnostics is proud to work alongside a ... Manager in Brea, California responsible for leading the Product Compliance program in support of new product introductions & sustaining product support . If you… more
- Cytiva (Miami, FL)
- …is responsible supporting the start-up and establishment of Laboratory Operations to support all parts of manufacturing from raw material testing to product release ... where you will perform analytical experiments, hands on problem solving, documentation , and report results.This position reports to the Manager, Quality Control… more
- Cytiva (Miami, FL)
- …manufacturing validation (IQ, OQ, PQ) and design assurance activities to support effective design transfers and product launches.This position reports to the ... an on-site role.What you will do:Review and approve change control documentation (ECOs) to mitigate risks to product quality.Conduct investigations into… more
- Pall (Miami, FL)
- …questions and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for ... Executes appropriately on product recalls. Respond to regulatory agency inquiries. Support the manufacturing lines when nonconformance exists to ensure appropriate… more
- Aldevron (Miami, FL)
- …alignment on labeling requirements, changes, and challenges. Provide guidance and support to these teams on labeling-related matters, including artwork creation, ... the application of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).Strong foundational knowledge in FDA and EU regulations… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …+ Administrators, Quality Control, Technical Services, Validation and Manufacturing management in support of providing documentation support for new product ... internal project commitments to minimize disruption of the project and provide documentation in support of business needs. + All other duties as assigned. **The… more
- University of Miami (Hialeah, FL)
- …other members of the healthcare team to ensure accurate, high-quality clinical documentation to support UHealth initiatives. Adheres to departmental and ... please review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . The Clinical Documentation Integrity Specialist 1 (CDIS) performs clinically based health… more
- Community Health Systems (Naples, FL)
- …medical records software, such as 3M 360 Encompass and Iodine Interact, to support documentation practices. + Utilizes approved physician query processes to ... **Job Summary** The Clinical Documentation Specialist (CDS) performs clinical documentation improvement (CDI) activities to support the accuracy, quality,… more
