Quality Assurance Analyst
4 weeks ago
Position: Quality Assurance Specialist
Company: BWX Technologies, Inc.
BWXT Medical Ltd. stands as a reputable entity in the field of nuclear medicine, providing development and manufacturing services to biotechnology, life sciences, and pharmaceutical sectors. With a dedicated workforce exceeding 300 professionals, BWXT Medical operates in various locations, focusing on innovation and quality.
Role Objective:
The Quality Assurance Specialist is pivotal in establishing and upholding the Quality Assurance System protocols, ensuring adherence to regulatory standards such as FDA, Health Canada, ISO 9001, ISO 13485, and European directives for pharmaceuticals and medical devices.
Reporting Structure:
Directly reports to the Director of Quality Assurance. Responsible for making critical quality-related decisions that influence the company's operational efficiency and product delivery. Evaluates and recommends actions based on quality system concerns and product manufacturing issues. Approves documentation related to quality, including audit reports, complaints, and corrective actions. Capable of making product release decisions and escalating issues within the Quality organization as necessary.Key Responsibilities:
Oversee the coordination of Medical Isotopes Quality Systems. Develop and implement quality procedures to manage product and process quality effectively. Collaborate with development teams on validation activities and change control processes. Conduct internal quality and supplier audits to maintain quality objectives. Initiate improvements in efficiency by refining methods and procedures. Provide training on Quality Assurance protocols to various internal teams. Maintain comprehensive QA systems and documentation to comply with applicable standards. Analyze customer feedback and audit results to ensure compliance with customer requirements. Offer Quality Assurance support to other departments and external contractors. Engage in product release activities and provide backup for the Quality Assurance Manager as needed. Perform additional related duties as required.Qualifications and Skills:
A degree in Life Sciences or Engineering, complemented by 2-5 years of experience in Quality Assurance or Quality Control within the pharmaceutical or medical device industry. Relevant certifications in quality auditing or ASQ certification are advantageous. Up-to-date knowledge of FDA, Health Canada, and European regulations is essential. Strong understanding of Good Manufacturing Practices (GMP) and ISO quality standards. Excellent analytical, problem-solving, and communication skills. Proficient in data analysis and quality auditing methodologies.Why Consider BWXT Medical?
Engage in the dynamic nuclear medicine sector alongside skilled professionals. Competitive salary and benefits package. Opportunities for professional development and growth. Supportive and inclusive work environment.BWXT Medical Ltd. is committed to fostering a diverse and inclusive workplace, ensuring equal opportunities for all qualified candidates. We value individuality and encourage unique perspectives in our workforce.
Job Segment: Quality Assurance, Pharmaceutical, Nuclear Engineering, Operations, Science, Engineering
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