Quality System and Document Control Specialist

We are currently seeking a proactive, reliable, and experienced Quality System and Document Control Specialist with outstanding interpersonal and technical skills. Interested candidates should have GxP and/or Clinical Laboratory Improvement Amendments (CLIA) experience.

Employment Type:

Full time

Key Responsibilities:

· 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 periodic review of documentation

· 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

· Accepts and adapts to change as directed; understands change is a constant and necessary path for improvement and growth

· Other duties as needed.

Qualifications:

· 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.

Job Type: Full-time

Pay: $65,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Work Location: In person

Salary : $65,000 - $80,000