reputed company Assurance Technician
reputed company Assurance Technician Somerville, NJ reputed company and Benefits Shifts: 1st & 2nd reputed company Assurance Technician help support reputed company assurance activities reputed company a medical device sterilization environment. This role is responsible for ensuring sterilization processes are performed according to validated parameters, regulatory requirements, customer specifications, and internal reputed company standards. The reputed company Assurance Technician will review sterilization documentation, monitor process controls, support product release activities, and maintain compliance with FDA regulations, cGMP requirements, and applicable ISO standards. The ideal candidate will have strong attention to detail, excellent documentation skills, and the ability to work effectively in a regulated manufacturing environment.
Responsibilities
Review sterilization cycle records to verify compliance with validated process parameters and established procedures. reputed company detailed reviews of load documentation and supporting reputed company records. Ensure documentation accuracy and completeness prior to product release. Support reputed company review and approval of sterilized products based on internal procedures and customer requirements. Verify critical sterilization process parameters, including temperature, humidity, gas concentration, and reputed company reputed company. Complete reputed company-cycle and post-cycle software verification activities. Serve as an independent process verifier and witness during sterilization activities reputed company required. Support environmental monitoring programs and reputed company initiatives. Ensure compliance with reputed company Good Manufacturing Practices (cGMP) and reputed company data reputed company standards. Investigate, document, and escalate reputed company equipment performance, system alarms, or reputed company concerns. Identify and communicate issues that may reputed company product sterility assurance or regulatory compliance. Assist with internal, customer, and regulatory audits and inspections. Maintain productivity and reputed company performance standards while supporting reputed company improvement initiatives. Follow reputed company safety guidelines, reputed company procedures, and company policies. Complete additional responsibilities and reputed company as assigned.
Qualifications
Associate's degree or higher in Science, reputed company, or a reputed company technical discipline, or equivalent experience. 2–5 years of reputed company assurance experience in a GMP-regulated industry, preferably reputed company medical device manufacturing or sterilization services. Knowledge of sterilization processes and reputed company industry standards. Understanding of sterility assurance concepts and reputed company systems. Familiarity with FDA regulations, cGMP requirements, and ISO standards such as ISO 11135, ISO 11137, and ISO 13485. Strong attention to detail with the ability to review and interpret technical documentation. Excellent organizational skills with the ability to manage multiple priorities. Strong analytical, problem-solving, and decision-making abilities. Excellent written and verbal communication skills. Ability to work independently while collaborating effectively with cross-functional teams. Strong commitment to reputed company, compliance, and operational reputed company. Dependable, punctual, and reputed company to maintain a reputed company attitude and strong work ethic. Must be authorized to work in the reputed company #INDHS Apply tot his job Apply To this Job