Amgen Specialist Quality Assurance in Woburn, Massachusetts
The Specialist Quality Assurance role will be responsible of developing, implementing, and conducting a spectrum of quality assurance activities within the Technical Team in the QA organization. These responsibilities include but are not limited to the oversight and/or day to day actions of the Quality Risk Management program, ownership of QA/QC Change Controls and tracking of all deliverables associated to audits and regulatory commitments until their completion/closure.
Facilitate Quality Risk Assessments (from planning to report issuance) towards effective implementation of process/product/system changes
Escalate significant quality issues to Quality management in a timely manner
Responsible of QRM metric reporting as per schedule.
Site liaison for QRM issues and provide input on opportunities for improvements and waste reduction to the system at QRA network meetings
Own and maintain site Quality Risk register
Support the change control program, with hands on ownership for QA/QC change control records and resolution of issues towards successful implementation of the change
Oversee and review data to ensure all site commitments are met timely and in a compliance fashion.
Perform comprehensive Quality review of documentation / data to support commitment closure
Ensure compliance of areas of responsibility
Perform other QA related duties to fulfill site business needs
Interface with Senior Management, auditors and regulators.
Doctorate degree OR
Master's degree and 3 years of Quality experience OR
Bachelor's degree and 5 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
Excellent written and verbal communication skills, including facilitation and presentation skills
Ability to communicate and collaborate effectively in group (with technical and senior management staff) or one-or-one settings
Knowledge of cGMP regulations, practices, and trends pertaining to Quality System / Processes
Demonstrated experience in quality assurance, quality systems, mainly Quality Risk Management and Change Control Process
Strong knowledge and experience in project management
Leadership skills, experience working within cross-functional teams, and ability to handle multiple assignments simultaneously in a fast paced environment
Understanding of biopharmaceutical bulk, drug product manufacturing and fill and finish (aseptic) processes
Trackwise database experience
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.