Your Role: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