A career with MilliporeSigma is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Performance Materials is a business of Merck KGaA, Darmstadt, Germany.
Cherokee Quality Control in St. Louis, MO, supports manufacturing of custom products including active pharmaceutical ingredients, excipients, and raw materials used within the health care industry.
This position within the GMP Quality Control department is responsible to support the development, validation, implementation and ongoing administrator support of a LIMS (Laboratory Information Management System) and other data systems.
ESSENTIAL JOB FUNCTIONS
- Support the development, validation and implementation of a LIMS for a GMP laboratory.
- Draft and review policy, procedures and protocols as assigned.
- Execution and/or review of scripts and test data associated with the validation of various software systems in the GMP laboratory.
- Work in accordance with current GMPs and GAMP requirements.
- Lead technical troubleshooting of data systems.
- Lead process improvements to improve laboratory performance.
- Prepare technical reports as assigned.
- Manage project milestones for internal and external customers to ensure on quality and on time success.
- Additional duties as assigned by QC Management.
Who You Are:
The ideal candidate has a broad range of experience with the validation, implementation and maintenance of various computer software systems in a GMP laboratory.
- BS/BA in a related life science or computer science field
- Strong understanding of GMP guidance and regulations for APIs, excipients and drug products
- Strong understanding of data integrity requirements, including the review of electronic audit trails
- Strong technical writing, root cause analysis and scientific reasoning
- Experience in lean lab practices and continuous improvement initiatives
- MS degree in a related life science or computer science field
- 5+ years of GMP experience in pharmaceutical, biopharmaceutical or similar industry
- 3+ years of GMP administration experience in LIMS, database, and/or CDS (Chromatography Data System)
- GMP experience with validation and the change control associated with validated computerized systems
- GMP experience with ELN (Electronic Lab Notebooks)
- Chemical environment- Must be able to perform tasks while wearing personal protective environment
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
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