Quality Specialist will lead the development and execution of Validation strategies, ensure Validation activities are performed in a consistent and controlled manner. Specialist will serve as primary investigator and NC owner for critical quality investigations that occur within operations supporting the manufacturing of bulk pharmaceuticals and provide quality oversight of operations ensuring products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP).
Specific responsibilities include but not limited to:
Provide Validation Quality oversight for Process, Computer, Equipment and Cleaning Validation.
Provide leadership and coordination of validation activities
Develop PPQ strategy for NPIs
Develop/Update Validation Master Plans
Quality review and approve Validation Documents including: DT, CRSIQ/OQ, RTM, FT/FTF, protocols, reports, etc.
Ensure alignment with regulatory guidelines and industry standards.
Review requirements and source documentation (MBRs, PDTs, PCSRs, SOPs, Specifications), for use in development of Validation documents
Provide guidance for the generation, resolution and closure of deviations.
SOP development, review and approval
Provide Change Control Assessments
Generate/facilitate quality risk assessments for automation and equipment (QRAES)
Participate in internal and external audits
Interpret and execute policies/procedures and lead validation engineers on an ongoing project basis
Coordination of activities between Amgen teams (Validation, Manufacturing, F&E, Automation, QC, etc.).
Doctorate Degree OR
Master's Degree and 2 years of Quality experience OR
Bachelor's Degree and 4 years of Quality experience OR
Associate's degree and 10 years of Quality experience OR
High school diploma/GED and 12 years of Quality experience
6 years of experience in pharmaceutical or biopharmaceutical environment with cGMP FDA regulated operations/engineering/manufacturing/quality environment Technical understanding of pharmaceutical/biotechnology unit operations
Direct Validation experience with pharmaceutical or biopharmaceutical processes including the development of strategies, master plans, protocols and reports.
Proven experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes
Strong skills in communication, presentation, organization, team development and leadership
Knowledge of risk-based validation methodologies, such as GAMP5, regulatory agency expectations, biopharmaceutical processes, project management, strategic resource management and business analysis
Ability to evaluate compliance issues and interact with regulatory inspectors
System knowledge and experience with EBR, Delta V, NC, CAPA and Change Control processes
Demonstrated experience in investigations, change control, validation and risk
System knowledge and training in Trackwise, SAP, MES (Werum PAS/X), and Maximo
Ability to manage multiple complex tasks at one time
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
A little about us:
Amgen values the leadership, skills and passion for serving that veterans exemplify and our constant commitment to hiring the best starts here.