This is an opportunity to serve as a department representative in Global Network meetings, and lead site and participate with cross-site meetings involving cross-functional teams. In addition, the Quality Assurance (QA) Specialist will participate in global Quality initiatives and will support the development of strategies ensuring the Amgen Rhode Island (ARI) site input is provided and leading ARI implementation activities.
Supporting the Quality Systems business processes at Amgen Rhode Island.
Execute Nonconformance, Corrective Action/Preventative Actions (CAPAs), Change Control and general Quality oversight responsibilities. Act as owner for ARI quality programs and procedures.
Utilize leadership qualities to influence outcomes, communicate with all levels of the organization, facilitate development of solutions to critical business issues and effectively define objectives to enable effective metric generation and reporting.
Provide quality assessments and propose strategic direction to achieve organizational success.
Act as a Subject Matter Expert for Quality Systems, programs and procedures. Provide daily oversight, guidance and support in regards to Quality Systems, Quality Policies and Procedures.
May also include working in a cross-functional capacity providing Validation Quality oversight for Process, Computer, Equipment and Cleaning Validation including Validation Master Plans, including supporting development of Validation protocols/reports and Quality review of documents while ensuring data integrity requirements are met.
Manage expenditures and work force model criteria to support business initiatives for department, site and organizational needs.
Perform project management for the department and lead/execute work center team methodologies.
Participate in ARI projects and continuous improvement efforts.
Develop and mentor junior staff.
Champion Operational Excellence Projects.
15% Domestic and International travel
Master's degree and 3 years of Quality, Manufacturing or Process Development experience
Bachelor's degree and 5 years of Quality, Manufacturing or Process Development experience
Associate's degree and 10 years of Quality, Manufacturing or Process Development experience
High school diploma / GED and 12 years of Quality, Manufacturing or Process Development experience
Experience in auditing and defending processes, procedures and decisions during regulatory inspections. Knowledgeable in current industry standards and regulatory trends as they pertain to Quality Systems, Compliance, Supplier oversight and Learning and Performance (Training) within pharmaceutical or biopharmaceutical processes.
5+ years manufacturing, process development or quality assurance experience in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, data analysis, project management, and quality systems.
Thorough understanding of quality management systems and quality control processes related to bulk drug and drug product for clinical and commercial operations.
Experience in pharmaceutical or biopharmaceutical environment with Good Manufacturing Practices (cGMP) Food and Drug Administration (FDA) regulated operations, engineering, manufacturing or quality environment. Technical understanding of pharmaceutical or biotechnology unit operations.
Previous exposure to bulk drug and drug product manufacturing processes and quality assurance processes.
Proficient working knowledge of European Pharmacopeia (EU) and United States cGMPs including computer related systems regulations.
Demonstrated ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively.
Experience in project management, process improvement and change control.
Demonstrated ability to navigate through ambiguity and provide a structured problem solving approach.
Organizational savvy and presence to build effective relationships across functions.
Track record of building or participating as a member of high performing teams.
Demonstrated ability to coordinate multi-functional project teams and deliver on schedule.
Demonstrated ability to coordinate and lead cross-functional teams.
Excellent interpersonal relationship skills.
Excellent oral and written communication skills.
Ability to work independently and as a team player.
Proficient with Microsoft Office including: Word, Excel, PowerPoint, Visio and Project.
Demonstrated ability to deliver results through living the Amgen values.
Negotiation skills when working with contractors and an ability to maintain remote working relationships with team mates at other Amgen sites.
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.