What are the responsibilities and job description for the Quality System and Document Control Specialist position at Proclinical Staffing?
Quality System and Document Control Specialist - Permanent - Rochester MN
Are you a dedicated and forward thinker looking for a new challenge?
Proclinical 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
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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