Brief Summary

Join a dynamic team as a Senior Quality Operations Specialist, where your expertise will contribute to maintaining high-quality standards and ensuring compliance in a vital operational environment. This role is critical for fostering a culture of continuous improvement and product excellence.

Responsibilities

Ensure compliance with site safety requirements and maintain a safe working environment. Provide quality assurance supervision and problem-solving support on the shop floor to uphold routine compliance. Perform quality monitoring for aseptic manufacturing processes and conduct acceptable quality checks for sterile products. Coordinate microbiology quality activities, including the examination of incubated media-filled vials. Support quality control efforts by reviewing essential QC documents and participating in operational readiness initiatives. Assist in batch disposition and review of validation documents, including system validations. Assess incoming materials for new products and draft operational procedures, reviewing all standard operating procedures (SOPs). Analyze shop floor data and collaborate with operations to resolve quality issues as a representative of QA. Review and approve Master Batch Records and Master Formulation Records, ensuring adherence to compliance standards. Maintain readiness for audits by regulatory bodies and clients, including involvement in deviation and out of specification (OOS) investigations. Lead root cause analysis initiatives and develop effective CAPA (Corrective and Preventive Actions) strategies, along with supporting validation processes. Continuously enhance quality assurance operations procedures to improve overall efficiency. Ensure site compliance with environmental health and safety protocols, promptly reporting any incidents or breaches.

Requirements

Bachelor's Degree or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a related field. A minimum of 4-6 years of relevant experience in Quality within the Pharmaceuticals or Biopharmaceuticals industry. Familiarity with Quality Management Systems and experience in quality operations and biologics/aseptic training is preferred.

QA Operations Senior Specialist (12hours Rotating Shift)