Quality Compliance Specialist
Temp To Hire
Our client provides solutions for biomolecular analysis, including real-time analysis of biomolecular interactions in micro-volume samples size, providing information on binding affinity, binding kinetics and concentration. Their products include instrumentation, software, biosensors and supporting services.
The Quality Compliance Specialist will be responsible for administering quality systems using basic skills and knowledge of appropriate procedures, methods and techniques, as well as applicable current good manufacturing practice and customer requirements. The holder of this position will help to ensure implementation, maintenance, and improvement of the quality system.
Main Responsibilities Tasks:
- Write and review Standard Operating Procedures SOPs
- Support ongoing process improvement endeavors
- Maintain and ensure applicable regulatory and internal QMS compliance for staff training/personnel files, master schedule, deviation trending/tracking, etc.
- Provide support for internal and sponsored projects including reviewing protocols and reports
- Work collaboratively with staff responding to and resolving deviations and incidents
- Follow through on corrective and preventative actions from deviations and audit observations
- Maintain databases for investigations, audit observations and CAPA Qualifications
- Bachelor s degree in Science, Engineering or related field
- 3-5 years related experience required
- Knowledge of requirements and relevant industry standard practices with a demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems
- Knowledge of quality systems and product/process lifecycle management within a manufacturing environment
- Proficient computer skills required
- Excellent communications skills both written and oral, including ability to navigate potentially challenging situations both internal and external to the business during the coordination of QMS programs
- Ability to quickly assess assigned task requirements, identify potential challenges, and communicate effectively in order to expedite the successful execution of assigned work
- Efficient organizational skills, including the ability to manage multiple processes and priorities effectively
- Ability to read, write and speak fluent English
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