|Date Posted||April 30, 2021|
A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works, and plays through next-generation advancements in healthcare, life science, and electronics. 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. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
This position is first shift in Verona, WI. Verona/Madison Quality Control supports manufacturing of active pharmaceutical ingredients. 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.
- Support the development, validation, and implementation of a LIMS for a GMP laboratory.
- Draft and review policy, procedures, and protocols as assigned.
- Author, execute, and/or review of scripts and test data associated with the validation of various software systems in the GMP laboratory.
- 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.
- Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
- Exercise judgment within generally defined procedures and practices to select techniques for obtaining solutions.
- Solve problems and make decisions with assistance.
- Perform preliminary review of analytical data for accuracy and quality.
- Maintain projects and timelines with minimal oversight.
- Participate in OOS and OOT investigations via testing and good documentation.
- Apply good problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with assistance from supervisor.
- Work cooperatively within the QC department and with other departments to achieve project goals.
- Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210, and 211 as applicable
- Work in a safe manner and maintain the cleanliness of the work environment.
- Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.
- Additional duties as assigned by QC Management.
- Work in a chemical environment
- Ability to perform tasks while wearing personal protective equipment (chemical protective clothing) for extended periods of time
- Occasionally lift and/or move up to 25 pounds unassisted and push and pull heavy materials to complete assignments. May lift more poundage with assistance.
- Utilize speaking and hearing.
Who You Are:
- Bachelors degree in Chemistry, Biology, Biochemistry OR another biological sciences discipline.
- 2+ years in a GLP or cGMP analytical laboratory environment.
- MS degree in a related life science or computer science field
- Experience with the validation, implementation, and maintenance of various computer software systems in a GMP laboratory
- GMP experience in pharmaceutical, biopharmaceutical, or similar industry
- 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
- 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