What are the responsibilities and job description for the Quality Assurance Specialist position at Integrated Resources, Inc ( IRI )?
As a Quality Assurance Specialist, you will play a vital role in ensuring that our company maintains the highest standards of quality control and compliance. Your primary responsibilities will include assisting with change controls, bill of materials, Oracle data management, customer audits, customer complaints, recalls, and quality test protocols.
- QMS (Quality Management System): Assist in managing and documenting change control processes to ensure all changes are properly evaluated, approved, and implemented in accordance with company policies and regulations. Handling of change controls, deviations, and CAPA in QAMS systems.
- Bill of Materials: Maintain accurate and up-to-date bill of materials (BOM) to support manufacturing operations, ensuring that all components and materials are correctly listed and documented.
- Oracle Data Management: Utilize Oracle or other data management systems to accurately record, track, and analyze quality-related data, ensuring data integrity and compliance with regulatory requirements.
- Customer Audits: Support customer audits by preparing necessary documentation, participating in on-site audits, and addressing any quality-related inquiries or concerns raised by customers.
- Customer Complaints: Assist in the management of customer complaints by investigating and documenting complaints, coordinating with relevant departments to address root causes, and implementing corrective and preventive actions.
- Recalls: Collaborate with cross-functional teams to execute production authorities and timely and effective communication with customers and regulatory authorities, and coordinating the retrieval and disposition of affected products.
- Quality Test Protocols: Assist in the development, implementation, and maintenance of quality test protocols, ensuring they are in compliance with regulatory requirements and industry standards.
- Internal Audit: Conduct Internal Audit and ensure compliance with the observation in a timely manner. Coordinating with other departments to ensure compliance to procedure.
- Coordinate, review, and compile batch related documents. Keep all GMP records in compliance with Good Documentation Practices.
- Liase with manufacturing facilities and testing laboratory to facilitate the timely release of lots.
- Review quality agreements with contract manufacturers.
- Carry out failure investigations for any non-conformities.
- Bachelor's degree in a scientific or related field.
- Previous experience in a quality assurance or quality control role, preferably in a regulated environment
- Knowledge of change control processes, bill of materials management, and data regulated industry such as pharmaceuticals, medical devices, or food manufacturing.
- Strong management systems experience (e.g., Oracle, SAP)
- Familiarity with regulatory requirements and quality standards (e.g., FDA regulations, ISO standards).
