Quality Assurance Specialist - Manufacturing Support

• Provide Quality oversight to ensure that Operations’ products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
• Perform review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA)
• Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports
• Oversee and provide guidance during on-the-floor analytical testing
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
• Ensure that changes that could potentially impact product quality are assessed according to procedures
• Ensure that deviations from established procedures are investigated and documented per procedures
• Alert senior management of quality, compliance, supply and safety risks
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation
• Identification and implementation of continuous improvement opportunities within our processes and systems
• Support and represent PQA during audits and inspections
• may directly interact with regulatory agencies during on-site inspections

High school diploma / GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Associate’s degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Bachelor’s degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Master’s degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Doctorate degree

• Educational background in Life Science or Engineering
• Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations
• Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition
• Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian)
• Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
• Experience participating in, managing, and responding to health authority inspections, partner and corporate audits
• Strong organizational skills, including ability to follow assignments through to completion
• Excellent written and verbal communication skills