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ELECTRONIC SYSTEMS COMPLIANCE SPECIALIST
| Details |
Country: USA
Location: Missouri-St. Louis Saint Louis, MO
Total applied: 38 Job Category:Quality Assurance/Safety
Location:Saint Louis, MO
Status:Full Time, Employee
Occupations:General/Other: Quality Assurance/Safety
Career Level:Experienced (Non-Manager)
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ELECTRONIC SYSTEMS COMPLIANCE SPECIALIST
Monsanto Company, based in St. Louis, MO, is a leading global provider of technology-based solutions & agricultural products that improve farm productivity & food quality. As a Fortune 500 company, Monsanto has been ranked as one of the top ten employers in the biotechnology industry by "Science" Magazine.
We have a challenging opportunity available for a successful candidate who is proficient in computer sciences. In this role the candidate will provide GxP quality assurance oversight, with an emphasis in the area of computerized system validation and electronic record handling for our headquarters in St. Louis, MO.
Responsibilities include:
- Performing electronic system validation activities according to approved methodology, protocols, SOPs and regulatory requirements
- Communicating compliance requirements associated with computer systems, electronic records and signatures to appropriate management and client departments
- Conducting inspections and audits to assure management that required processes are followed and associated documentation is accurate
- Performing process and facility inspections to assure management that electronic record handling and security measures are in compliance with GLP/GMP regulatory requirements
- Reviewing software development processes and documentation
- Assisting in training programs related to computer validation
- Periodically assisting in the pre-placement evaluations of contract facilities or service providers
- Serving as a resource and consultant for GxP regulation interpretation
- Assisting personnel in the understanding and implementation of quality or compliance improvement projects
The successful candidate will possess:
- B.S./M.S. degree in computer science or BS/MS degree in one of the biological or chemical sciences with significant computer science coursework
- Detailed knowledge of the software development life cycle and IT processes
- 5+ years experience in a QC/QA role with responsibility for electronic system compliance and computer validation in a GLP and/or GMP environment
- Demonstrated leadership experience in quality/compliance systems development
- Excellent communication (written and oral), interpersonal, organizational and negotiation skills
- Ability to interact effectively with team members, internal and external customers on fast paced projects
Desired skills/education/experience/attributes:
- 3+ years experience in the biotechnology industry.
At Monsanto, we offer a highly competitive salary & benefits package with career development opportunities in a team-oriented working environment. To apply on-line, please visit the Careers section of our website at www.monsanto.com & to apply online select req. number mons-00008398.
Monsanto is an EOE. We value diversity.
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