天涯社区官网

Quality System and Document Control Specialist - Permanent - Rochester MN

Are you a dedicated and forward thinker looking for a new challenge?

天涯社区官网 are currently seeking a proactive, reliable, and experienced quality assurance specialist with outstanding interpersonal and technical skills. Interested candidates should have GxP and/or Clinical Laboratory Improvement Amendments (CLIA) experience.

Skills & Requirements:

• Bachelor's degree in quality assurance or science-related field.
• Minimum of 3 years in document control and/or quality system operations.
• Extensive QMS knowledge including ISO 9001.
• Experience participating in internal and external audits
• Experience with CAPA, complaints, risk management, and supplier management
• Strong management skills, including the ability to facilitate and organize
• Ability to effectively communicate with customers and regulatory agencies
• Ability to communicate effectively with subordinates and motivate personnel to achieve efficient workflows and methods
• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines
• Possess excellent interpersonal skills, being able to consult and work with multi-disciplined teams.
• Possess excellent verbal and written communication skills, including the ability to understand and verify scientific text and data.
• Strong advanced computer skills.
• Experience with eQMS (Qualio) is a plus.

The Quality System and Document Control Specialist's responsibilities will be:

• The Quality System and Document Control Specialist is responsible for coordinating and managing quality documentation within a controlled system
• They work with product development, marketing, operations, regulatory, quality, and science departments to ensure procedures are followed and records are maintained for the products and services provided.
• They ensure the Quality Management System (QMS) is properly maintained and compliant with regulations and customer requirements.
• Ensure and support compliance with the company's Quality Manual, Quality Policy, and Quality Objectives
• Develop quality metrics and coordinate the data collection and analyses for Management Reviews
• Participates in internal and external Quality Audit processes with internal customers and third parties, including regulatory organizations
• Monitor and maintain the training program
• Document and evaluate changes through the internal change control process
• Coordinate with various departments to ensure effective and timely task completion
• Change Management - Accepts and adapts to change as directed; understands change is a constant and necessary path for improvement and growth
• Other duties as needed.

If you are having difficulty in applying or if you have any questions, please contact Eloise Coly at e.coly@proclinical.com

天涯社区官网 is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

天涯社区官网 Staffing is an equal opportunity employer.

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