Corteva Agriscience has an exciting opportunity for GLP QA Specialist (Archivist / Auditor) role based in Indianapolis, IN.
Who are we, and what do we do?
At Corteva Agriscience, you will help us grow what’s next. No matter your role, you will be part of a team that is building the future of agriculture – leading breakthroughs in the innovation and application of science and technology that will better the lives of people all over the world and fuel the progress of humankind.
The GLP specialist’s primary responsibilities include ensuring compliance with Good Laboratory Practice (GLP) standards. This position will receive, maintain, and manage any data and associated records within the archives in accordance with applicable GLP regulations, SOPs, and company policies. As necessary, he or she may be asked to conduct or assist with inspections and audits that may include study critical phases, facility inspections and others as applicable.
How will you help us grow? It matters to us, and it matters to you!
- Maintain a computer-based index inventory system for accurate tracking/retrieval of GLP and non-GLP archived records (e.g., testing data, facility data, and any other relevant documents).
- Create, maintain, and execute processes related to all documentation, records, raw data, and specimens pertaining to divestitures and off-site permanent storage. Maintain and execute processes related to all records pertaining to off-site permanent storage. Train other team members identified to serve as back-up for Archive responsibilities.
- Ensure movement and handling of records in and out of the archives is properly controlled and documented. Manage customer requests for archived data.
- Ensure archiving processes meet regulatory requirements including limited access and expedient retrieval.
- Retrieve and/or scan documents requested by government agencies or internal stakeholders.
- Coordinate receipt and verification of incoming Corteva study packages from Contract Research Organizations (CRO’s).
- Monitor archive environmental conditions and security access to the archive and resolve issues as needed. If internal or external satellite archives are maintained, then this role will be responsible for oversight to ensure requirements are met.
- Conduct audits that may include critical phase, facility inspections, and other Corteva specific audits.
- May participate in projects and initiatives as needed.
What expertise have you grown? What do you bring to the table?
- BS degree in chemistry, biology or related scientific field is required. Previous scientific and/or regulatory experience (minimum 3-5 years) is desired.
- Knowledge of the GLP Standards strongly desired.
- Experience in archiving or document management preferred
- Preferred previous experience with quality management systems.
- Experience in regulated environment preferred
- Experience with electronic document management desired
- Ability to understand, follow, and implement SOPs, regulations, and other written guidance required.
Other Competencies: (Contributes Independently)
- Balances Stakeholders: Builds internal and external stakeholder relationships. Demonstrated agility in changing demands and ability to deal with uncertainty.
- Collaborates: Promotes a culture of collaboration across the Corteva quality and stakeholder teams. Ability to work with and influence peers and management.
- Cultivates Innovation: Fosters a climate that supports allocated resources to be creative and innovative, leading to implement breakthrough ideas and solutions.
- Values Differences: Supports an environment where all people feel respected and appreciated and actively takes steps to advance the careers from multiple backgrounds and cultural differences.
- Exceptional organizational skills with high attention to detail
- Ability to handle confidential information appropriately
- Ability to work effectively and independently in a fast-paced/multi-task environment
- Ability to effectively communicate, build, and maintain successful relationships
- Ability to prioritize workload based upon compliance requirements and departmental timelines
- Resolve issues/problems identified relative to GLP standards; confers with supervisor on unusual matters.
- Proficiency in MS Office Suite and Adobe applications
- Strong customer focus and time management skills
- Demonstrate Corteva culture and market shaper behaviors.
Let’s peek at how you can grow your wellbeing, health, and future at Corteva!
- Strike a better work-life balance with robust time off benefits including paid maternity, paternal and family illness leave
- Prepare for your future with our competitive retirement savings plan, tuition reimbursement program, and more
- Enjoy access to health benefits for you and your family on your first day of employment
- And much, much more!
We care about you, and we care that you're comfortable. While there's no place like home, Corteva comes close.
At Corteva Agriscience, you will help us grow what’s next. No matter what your role, you will be part of a team that is building the future of agriculture – solving the world’s food problems through innovation, technology, and putting people first.
Ready to grow your perspectives, impact and career? Start by applying to this opportunity today!