Insurance Coordinator at Mercer Advisors executing insurance coverage tasks and managing policies across product lines. Engaging with clients, brokers, and internal departments for policy management and client service.
About the role
- Global Sterility Assurance Specialist leading sterility assurance standards and compliance efforts for pharmaceutical manufacturing. Collaborating with teams to ensure adherence to regulatory requirements and drive continuous improvement.
Responsibilities
- Provides strategic leadership to the site related to sterility assurance standards, culture and continuous improvement
- Perform effective regulatory and business intelligence about sterile manufacturing and Sterility Assurance
- Work collaboratively with the global sterility assurance teams to provide a holistic microbial contamination control strategy and improvement plan at the site
- Partners closely with the global function leads as well as site leadership team, develops strategies to ensure continuous adherence to regulatory and CSL standards related to sterility assurance governance and drive improvements
- Provides expert input to Sterility Assurance related major deviation investigations in the area of sterile filtration, aseptic filling and lyophilization and sterility, media fill and bioburden test fail
- Plays a proactive role in the investigation of accidents and near misses as well as in the implementation of corrective actions
- Proactively works with sites and global stakeholders on inspection readiness for the sites (before, during and after inspections)
- Provides CMOs and filling strategies Sterility Support (CMO selection process, technologies intelligence…)
- Provides strong Sterility Assurance background and support on strategic CSL projects (i.e. new filling lines selection and design)
- Develops and leads Sterility Assurance Roadmaps for compliance and performance
- Ensures appropriate development, implementation and maintenance of sterility assurance standards and processes consistent with global governance, regulatory requirements and industry standards.
Requirements
- Bachelor's degree in Microbiology or Biology or life sciences or equivalent relevant field
- 8-10 years' experience in pharmaceutical manufacturing industry with direct experience executing quality assurance within a manufacturing and QC microbiology, sterility assurance context
- Demonstrated experience in quality assurance and regulation compliance with GxP, FDA, EU and other regulatory agency guidelines
- Experience interacting with regulatory authorities including submissions and inspections; knowledge of auditing practices and procedure
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Wound Care Verification/Authorization Specialist verifying patient eligibility for health care services at InfuSystem. Collaborating with healthcare providers for necessary authorizations and documentation support in a hybrid work environment.
Reinsurance Officer coordinating reinsurance processes among departments like Finance, Actuarial, and Underwriting at AIG. Overseeing contract compliance and maintaining broker relationships.
Insurance Coordinator at Fresenius Medical Care supporting dialysis patients. Educating on insurance options and coordinating financial assistance while complying with regulatory requirements.
Technical Analyst providing first - level technical analysis and incident response for Comcast Business Managed Services. Working with managed broadband, Wi - Fi, and router solutions, and involving troubleshooting incidents.
Senior Controls & Assurance Specialist enhancing WPS’ risk maturity through control testing and governance processes at M&G in the UK.
Claims Advisor for a leading vehicle insurance company, managing claims and ensuring customer satisfaction with efficient processes. Critical role in accuracy and regulatory compliance in compensation cases.
Sales Associate generating leads and managing client relationships for restoration services in Charlotte, NC. Balancing time between in - office and remote work to maximize productivity and client engagement.
Business Growth Specialist dedicated to helping commercial clients secure the right insurance solutions fast. Driving inbound sales and converting leads into bound policies for small business clients.
Senior Reinsurance Analyst managing oversight of syndicates’ reinsurance portfolios and their reinsurance operations. Involve in monitoring and managing reinsurance strategies and conducting reviews.