Senior Associate Plant Quality Assurance

Under minimal supervision, the Senior Associate Plant Quality Assurance is primarily responsible for performing quality review of documentation to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. Duties focus on providing quality guidance during on-the-floor manufacturing activities.

Responsibilities:

• Perform On-The-Floor (OTF) quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents (electronic and paper based).
• Author/review quality documents, such as: SOPs and Batch Records (electronic and paper-based)
• Execute daily operations per management guidance in a dynamic environment.
• Perform daily OTF inspections to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards.
• Provide guidance during on-the-floor manufacturing and testing.
• Support audits, inspections and investigations.
• Adhere to LEAN practices and contribute to culture of continuous improvement.

Basic Qualifications

Master's Degree

OR

Bachelor's Degree and 2 years of Quality experience

OR

Associate's degree and 6 years of Quality experience

OR

High school diploma/GED and 8 years of Quality experience

Preferred Qualifications

• Strong cGMP and GDP behaviors
• Demonstrated experience with deviations and CAPA records
• Previous experience supporting GMP facilities.
• Knowledge of electronic systems including LIMS, Trackwise, and Maximo
• Strong organizational skills and ability to manage multiple tasks at one time
• Ability to follow assignments through to completion and meet timelines
• Exposure to regulatory agency inspectors or participation in regulatory agency audits.
• Strong technical communication skills, both written and oral
• Demonstrated ability to work as a team player and independently

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.