Quality Assurance Analyst
4 weeks ago
Quality Assurance Specialist
Company: BWX Technologies, Inc.
BWXT Medical Ltd. is recognized as a reliable provider for the creation and production of nuclear medicine, serving biotechnology, life sciences, pharmaceutical enterprises, and academic collaborators.
The Quality Assurance Specialist role is pivotal at our manufacturing site, focusing on the establishment and upkeep of Quality Assurance System protocols to ensure adherence to various regulatory standards, including those set by the FDA, Health Canada, ISO 9001, ISO 13485, and European regulations for drugs and devices.
JOB STRUCTURE & COMMUNICATIONS:
Reports directly to the Director of Quality Assurance. Responsible for making critical quality-related decisions that influence the company's ability to deliver products and services efficiently. Provides recommendations based on operational concerns regarding quality systems or manufactured products. Reviews and approves quality-related documentation, including Change Controls, audit reports, complaints, and Corrective and Preventive Actions. Capable of making product release decisions and escalating issues within the Quality organization when necessary.ACCOUNTABILITIES:
Oversees the coordination of Medical Isotopes Quality Systems. Establishes quality procedures for managing product and process quality, guiding divisions in developing quality and continuous improvement plans. Assists development teams with validation activities and change control reviews. Conducts internal quality and supplier audits to uphold company quality objectives. Initiates actions to enhance efficiency in assigned responsibilities by refining methods and procedures. Supports customer and regulatory audits. Maintains quality data collection and analysis to enhance product design and quality systems. Provides training on Quality Assurance procedures to internal teams, including Production and Research and Development. Develops and maintains necessary QA Systems and documentation to comply with applicable quality and regulatory standards. Monitors customer feedback and conducts audits to ensure compliance with customer requirements. Offers Quality Assurance support to other departments and external contractors. Engages in product release activities and may back up the Quality Assurance Manager. Performs additional duties as required.KNOWLEDGE AND EXPERIENCE:
Typically requires an undergraduate degree in Life Sciences or Engineering, with 2-5 years of experience in Quality Assurance or Quality Control within a pharmaceutical or medical device context. Certification in quality auditing or ASQ certification is advantageous. Must stay informed about regulations from the FDA, Health Canada, and Europe to ensure compliance of Quality Systems and validation practices. Comprehensive understanding of Good Manufacturing Practices (GMP) for Pharmaceuticals and medical devices, along with ISO quality standards. Strong judgment, problem-solving, and analytical skills are essential. Ability to grasp complex operations from a holistic perspective. Proficient in quality auditing methodologies. Excellent organizational and communication skills, both verbal and written. Capability to analyze data and determine corrective actions. Demonstrated proficiency in computer systems.Why consider BWXT Medical?
Engage in the dynamic nuclear medicine sector alongside skilled professionals. Competitive salary offerings. Company-matched pension plan. Comprehensive health and dental benefits. Education reimbursement opportunities. Life insurance coverage. Collaborative work culture and more.BWXT Medical Ltd. values diversity of thought, promotes individuality, and provides equal employment opportunities for all qualified candidates. The company is committed to fostering an inclusive environment where all employees can thrive.
Job Segment: QA, Quality Assurance, Pharmaceutical, Nuclear Engineering, Facilities, Quality, Technology, Science, Engineering, Operations
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