Job Description
The Quality Assurance (QA) Specialist is a senior and active role within the broader QA function. QA specialists will be required to understand and grasp a broad range of quality related competencies. The QA Specialist will report to the PQA Packaging & Complaints Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility, including Packaging, Combination Products, Complaints. 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. QA Specialists may be assigned to a specific Quality functional area, for which the general functional area and duties are outlined below and for which candidates may be required to fulfil one or more of these duties. Additional responsibilities commensurate with QA Specialist level may extend, but not be limited to undertaking one or more other core responsibilities including; Participation in self-inspection program in a lead auditor or auditor capacity. Inspection readiness activities and hosting of internal and external Board of Health inspections, inclusive of providing QA technical expertise during audits/inspections. Support and represent Quality during audits and inspections Quality Risk Management execution/facilitation Provision of QA Subject Matter Expertise for complex investigations and associated CAPAs, as required. Metric reporting, monitoring and representing the Quality Assurance function at cross-functional meetings and external forums. Provision of Quality Oversight and partnership for internal and external customers Assuming site or business process owner roles, and active participation at network meetings and external forums. Key Responsibilities Provide overall quality direction and oversight for Packaging area, which will include associated support functions: Process Development, Validation, Supply Chain, Engineering, Information Systems, ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations. Provides real-time QA oversight and support for Production Operations and Plant QA Senior Associates in the Packaging Hall, by providing Purposeful Quality presence on the review and approval of GMP records (i.e. design qualifications, SOPs, protocols) Collaborates with Operations to resolve quality and compliance issues, including but not limited to Change Controls, Deviations and CAPAs. Ensuring the scope of Quality records are clear and the implementation corrective and preventative measures are robust and timely. Support a safe working environment by complying with all pertinent environmental health/safety practice rules and regulations Supports Lean Transformation and Operational Excellence initiatives In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role. Successful candidates will typically be educated to degree level in a Scientific or related discipline and ideally will have acquired technical skills and demonstrated competencies across a broad range of quality related disciplines. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives. Qualifications University degree. Science or Engineering related discipline preferred. Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems) Experience working with combination products or devices in packaging-related or complaint-handling activities Experience in change control, non-conformance, corrective and preventative actions. Ability to operate across functional boundaries, both internal and external. Ability to work independently and remotely with minimum direct supervision. Critical thinking skills. Strong organisational, communication, coordination, and meeting facilitation skills. Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. 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.