The Specialist Quality Assurance (QA) will assume the responsibility for Quality oversight supporting Amgen Thousand Oaks Manufacturing Organization. This individual is the primary QA point of contact for new product introductions, nonconformance investigations, process/facility changes, and corrective actions for one or more areas of operation. This individual will play an integral role within a cross-functional leadership team that includes Manufacturing, Process Engineering, Process Development, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
While serving as a primary cGMP contact for the Amgen Plant leadership team, this position has designated owner and approver responsibilities that may include but are not limited to:
New product introductions (NPI)
CAPA (Corrective Actions / Preventative Actions)
Operating and Manufacturing Procedures
Audit liaison and commitment tracking / closure
Project team participation and leadership
Equipment and System Validation
Additional responsibilities include management and evaluation of compliance issues/regulations, assure progress against commitments to regulatory agencies, identify compliance gaps and lead focused teams to resolve compliance issues, provide written compliance assessments to management on request, and interpret global regulations and apply them to a multi-product, multi-modality environment.
Master's degree and 3 years of GMP or Quality experience
Bachelor's degree and 5 years of GMP or Quality experience
Associate's degree and 10 years of GMP or Quality experience
High school diploma / GED and 12 years of GMP or Quality experience
Degree in Biology, Chemistry, or Engineering
Experience with cGMP Production environments and an understanding of its regulatory requirements
Experience with SAP and Supply Chain concepts
Experience with TrackWise for supporting Nonconformance investigations, CAPA, Change Control and Complaints
Demonstrated ability with project management (principles and techniques), initiating and leading cross-functional teams, and a strong knowledge of and experience with processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development
Experience participating in, managing, and responding to corporate audits/regulatory inspections
Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
Analysis of complex problems and delivery of clear and timely feedback
Strong interpersonal skills
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.