Quality Specialist II

Job description

Come Be Part of a Mission that Matters! Quality Systems Specialist: We are seeking an individual to support Quality Systems management by executing various activities such as corrective actions, batch record reviews, documentation maintenance, supplier quality, and audit program administration. This role ensures compliance with ISO standards, cGMPs, and customer expectations while providing training and support for quality policies and procedures. Schedule: Monday - Friday, 2nd shift (2:30 PM - 11:00 PM Responsibilities: Qualifications: - Utilize and monitor manual and software programs within the quality management system. - Identify areas requiring additional quality support or corrective/preventative actions. - Provide training and support on quality systems, policies, and procedures. - Assist in maintaining and communicating company quality policies and procedures. - Issue and audit batch records and manufacturing procedures. - Assist in ISO and internal audits as needed. - Support the writing of SOPs, product standards, and batch records. - Maintain documentation related to change control, operations, batch records, training, validations, calibrations, and qualifications. - Tr...