QC Microbiology Data Reviewer and Writer
Sunrise Systems Inc
Indianapolis, IN
Job ID: 25-11788
Location: Indianapolis, IN (Onsite)
Duration: 12 Months
Work Schedule: Monday - Friday, Business Hours (Weekends and Holidays as needed)
Key Responsibilities
- Perform an independent and thorough review of QC microbiology data for completeness, accuracy, and cGMP compliance
- Verify raw data, calculations, instrument outputs, electronic records for assays including but not limited to bioburden, sterility, endotoxin, media qualification, and environmental monitoring
- Confirm adherence to SOP's, test methods, and approved protocols
- Ensure documentation meets ALCOA+ data integrity principles
- Identify discrepancies, errors or atypical results and work with analysts to resolve issues and ensure right the first-time documentation
- Review EM results and ensure proper escalation of out of trend or excursions findings
- Write deviations, CAPAs and revise SOP's
- Write monthly / quarterly reports for environmental monitoring
- Support internal and external audits by providing clear, complaint documentation
- Minimum 4 years' experience in GMP microbiology laboratory data review
- Knowledge of Bioburden, Endotoxin, Sterility, Media qualification, and Environmental Monitoring
- Experience in writing and supporting investigations, deviations, or CAPA processes and SOPs.
- Experience with Sherpa or other LIMS
- Intermediate level MS SharePoint experience
- SAP experience preferred
- Bachelor's degree in microbiology, Biology, or Biotechnology or equivalent
- Preferred training in Quality systems, cGMP, and Data Integrity
Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com
About the Company
Sunrise Systems Inc
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.