Quality Assurance Specialist - Manufacturing Support

Quality Assurance Specialist In this vital role you will serve as Quality Assurance Specialist responsible for Plant Quality Assurance (PQA). This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. You will coach and guide Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regards to compliance and quality systems. Responsibilities 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 company requirements relating to GMP, GxP, safety and other controls. Review and approve 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 and approve quality documents such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports and validation protocols/reports. Oversee and provide guidance during on‑floor analytical testing. Ensure that production records and testing results are complete, accurate and documented according to written procedures and cGMP requirements. Assess changes that could potentially impact product quality according to procedures. Investigate and document deviations from established procedures per procedures. Alert senior management to quality, compliance, supply and safety risks. Provide project management support, lead efforts to drive timely achievement of tasks and develop strategies for system implementation. Identify and implement continuous improvement opportunities within processes and systems. Support and represent PQA during audits and inspections; interact with regulatory agencies during on‑site inspections. Qualifications Basic Qualifications High school diploma / GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience. Associate’s degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience. Bachelor’s degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience. Master’s degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience. Doctorate degree. Preferred Qualifications 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 with cell banking, cell culture and protein purification operations. Experience with Quality Management Systems, including exceptions, change control, risk management and disposition. Familiarity with computer and 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 and deviation investigations. Experience participating in, managing and responding to health authority inspections, partner and corporate audits. Strong organizational skills, including the ability to follow assignments through to completion. Excellent written and verbal communication skills. What You Can Expect Of Us In addition to a competitive salary, Amgen offers comprehensive total rewards aligned with local industry standards. We support professional and personal growth through collaborative culture and well‑designed benefits packages. Amgen is an Equal Opportunity Employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or any other basis protected by applicable law. Reasonable accommodations will be provided for individuals with disabilities. #J-18808-Ljbffr BioSpace