Job Description

As the Quality Assurance Officer you will have the opportunity to be a subject matter expert for quality at our Bellshill site; You will analyze data, conduct investigations and audits to support us in being fully compliant, an exciting element to this role will be to act as the program coordinator to improve and enhance processes, procedures, and practices including maintenance, supplier qualification, and preventive maintenance.

We are deeply rooted in our behaviors and taking care of our employees, working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. We want great people who share our passion for science and have the drive and determination to make a difference.

What you will do as a Quality Assurance Officer

• In partnership with process participants, process owners, and stakeholders, implements, maintains, and improves procedures for the quality management processes under his/her area of responsibility
• Assist in the development, documentation and deployment of quality system documents and processes throughout the organization
• Works and communicates effectively across departments to implement QMS improvements and to maintain its effectiveness
• Program coordination for one or more of the following QMS processes: the corrective action program, the internal quality audit program, supplier qualification, calibration and preventive maintenance
• Review batch records for conformity and materials released/rejected as appropriate
• Assist in the determination and delivery of quality system training requirements
• Assist with the maintenance, execution and improvement of non-conformance investigations, equipment qualification, supplier qualification, customer complaints, process deviations and training records
• Generate and review production deviations, compliant investigations, and non-conformance reports for non-conforming materials
• Review material and product specifications and the acceptance criteria for equipment qualifications and process validations

Required Knowledge, Skills, and Abilities

B.S. in the life sciences or a related natural sciences or engineering discipline. Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar professional certifications in quality management desirable. Biotechnology, medical device, or pharmaceutical knowledge and understanding of ISO 9001:2015 quality system standards required. Knowledge of Lean Manufacturing and continual improvement skills such as Six Sigma, Kaizen and 6S is highly desirable.