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Clinical Quality Specialist

LanceSoft Inc, Minneapolis minnesota

Performs review and approve reports for qualitative and quantitative analyses of organic, inorganic compounds and biomaterials testing that are intended to
support work under GLP/ISO regulations.

Responsibilities:
¿ Analyzes, review and approve testing reports to ensure that the data is reliable.
¿ Report any inconsistency or incorrect result observed during review reporting. Initiate an investigation.
¿ Interfaces with internal clients to meet requirements for quality and timeliness of results.
¿ Ensure compliance to regulations
¿ Performs other position related duties as assigned

Basic Qualifications;
Background
¿ Educational: Chemistry or related field (bachelors minimum)
¿ Experience:
o Intermediate Level: 3+ Years with Diploma/ Degree or 0 Years with Advanced Diploma/ Degree
o Senior Level: 5+ Years with Diploma/ Degree or 3+ Years with Advanced Diploma/ Degree
¿ Exposure to laboratory and manufacturing environment.
¿ Demonstrated practical application of chemistry knowledge and laboratory skills to analyze/characterize drug products and polymer materials
¿ Experience in data reviewing and approval process.
¿ Experience in Lab OOS/OOT and investigation techniques.
¿ Experience in execution of CAPAs
¿ Experience conducting Quality Assurance tasks.
Skills
¿ Analytical Thinking
¿ Problem Solving
¿ Interpersonal Relations
¿ Quality and Results Oriented

Desired:

Background
¿ Experience in medical device, pharmaceutical, or electronic industry
¿ Knowledge in Qualification / Validation activities
Skills
¿ Teamwork
¿ Communications
¿ Continues Improvement
¿ Project Management
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