City: Roseville State: MN Career Level: 4
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Skills: Good understanding of manufacturing processes and Quality Management System concepts.
Good oral, written, and interpersonal skills, ability to function effectively in a team and manage time efficiently, customer focused approach to activities and interactions.
Ability to work independently with initiative, good planning and organizational skills, flexibility for changes in work priorities and amount of activities.
Good decision making and problem-solving skills, demonstrated understanding of cGMPs, ability to apply cGMPs, recognize variances from cGMPs, completes routine tasks with little or no oversight and requires moderate direction to complete more complex tasks. Education: 2 Requirement: Bachelor’s degree in scientific field, preferably Microbiology
Two (2) or more years in the pharmaceutical and/or biopharmaceutical industry in a Quality Assurance role, preferably Quality Systems.
Experience in 21 CFR 210, 211, 600, 610 GMP regulations. Knowledge of standards, current industry practices, and familiarity with interpretation and application. Description: Location:Roseville, Minnesota
Job Description
The Quality Systems Specialist I is primarily responsible for implementing, maintaining and improving quality systems processes and programs to include: Supplier Quality, Audit, Investigation Systems, Periodic Product Review, Product Complaint, Regulatory Inspections, Document Control, Change Management, Training, and Technical Document review. This position may support one or many of the Quality Systems and Compliance functions.
Additional Information
All your information will be kept confidential according to EEO guidelines.
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