Job Description
The Quality Assurance (QA) Snr Associate will report to a Snr QA Manager and is a core member of the site Quality Assurance team. The QA Snr Associate will serve as Quality point of contact for Packaging operations, as well as support the complaints function. The site is focused on continuous improvement of all work processes and practices, therefore i n addition to routine Quality Assurance duties, QA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities. A variety of shift patterns may be required to support packaging operations, including but not limited to shift. Weekend work may also be required on occasion. Key Responsibilities: Perform all activities in compliance with Amgen safety standards and SOPs Observe and provide real-time Quality oversight and support for Packaging unit operations. Perform Finished Pack Quality audits- "Pack checks", on each finished labelled and packaged lot during batch operations. Decision maker on classification of defective units found during combination product assembly, and labelling and packaging processes in accordance with the on-site defect manual Provide Quality support for triage of production atypical events. Guiding the cross functional work centre team on the rationale for continued operation and appropriate next steps to ensure Product Quality requirements are met Perform Quality oversight of deviations, ensuring compliance with appropriate documentation. Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities. Provide training and advice to staff in order for them to perform their desired functions. Write, review and approve Standard Operating Procedures in accordance with Amgen Policies. Support continuous improvement and Operational Excellence initiatives Participates in Customer complaint investigations by virtue of completion of complaints based retrospective batch record review, and also as a team member in Cross functional Root cause analysis investigations Any other tasks/projects assigned as per manager's request. Basic Qualifications & Experience: University degree. Engineering or Science related discipline preferred. Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role. Preferred Qualifications & Experience: Excellent written and verbal communication skills Experience working with dynamic cross-functional teams and proven abilities in risk based decision making Strong organizational skills, including ability to follow assignments through to completion Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations Experience working with combination products or devices in packaging-related or complaint-handling activities Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues Operational Excellence experience To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.