Organizes, conducts, and monitors laboratory compliance activity. Responsible for CTU alarm response and resolution, review and reconciliation of lab audit checklists, and ensuring compliant laboratory practices.
Participates in routine lab maintenance, lab safety, ISO and QSR implementation.
Establishes as appropriate internal/cross-functional/customer relationships.
Monitors lab supply inventory, generates expense purchase requisitions, inputs production data and other work-output data into appropriate network (e.g. SAP, RAM, etc.) or departmental database, and maintains documentation in accordance with established procedures.
Participates in internal/external teams and relationships.
Creates/reviews/maintains asset inductions, general change requests, and equipment records within the Regulatory Asset Management system.
Demonstrates ability to follow Standard Operating Procedures (SOP) and Directions for Testing (DFT) documents. Demonstrates
competence in reading and completing charts, forms, and other documents. Ability to use personal computer with basic word-
processing and spreadsheet applications. Good written and verbal communication skills highly desirable
Prior LAB experience is not necessary- 0-2 Years General laboratory experience preferred. Basic GMP Knowledge
High School Diploma, or related field, or equivalent combination of education and work experience.
BS Degree Preferred
Planet Pharma - 11 months ago
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