Career Category

Job Description

Specialist – Quality Assurance

Job Summary

The Quality Assurance Specialist will be responsible for ARI site Change Control Business Process Owner (BPO) and PQA Off the Floor activities (Administrative shift). The focus of this role will be to support the change control network as the ARI site change control BPO and support PQA Off the Floor activities.

The PQA off the floor team provides coaching, guidance and direction to Manufacturing, Quality Control, Process Development, Supply Chain and Facilities & Engineering staff regarding compliance and quality systems. This position provides the opportunity to work directly with the change control network and Global Process Owner (GPO) on change control process changes, ARI site management reviews metrics, develop and deliver learning group trainings. Additionally, this position also provides opportunities to work with Manufacturing, Quality control (QC), Facilities/Engineering and Process Development on major deviations, change controls, CAPAs, New Product Introductions/Reintroductions and Site projects etc

Responsibilities include the following:

• ARI site Change Control Business Process Owner (BPO), work with the change control network and Global Process Owner (GPO) on change control process changes, global and site MR metrics, develop and deliver learning groups trainings, support ARI site with change control process questions.
• Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
• Perform QA review, and approval of cGMP processes, procedures, documents and records, including but not limited to Deviations, Corrective Action/Preventative Actions (CAPA), Change Control records, validations, and Raw Materials and Drug Substance documentation.
• Establish and enable LEAN practices. 
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Alert senior management of quality, compliance, supply and safety risks.
• Complete required assigned training to permit execution of required tasks.
• Drive operational improvement initiatives, programs and projects.

Basic Qualifications

Doctorate degree

OR

Master’s degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience

OR

Bachelor’s degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience

OR

Associate’s degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience

OR

High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience

Preferred Qualifications

• Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
• Previous QA oversight of manufacturing, analytical and engineering activities
• Experience in change controls, deviation investigations, and CAPAs processes system knowledge
• Ability to evaluate compliance issues and interact with regulatory inspectors
• Experience and training in Trackwise, CDOCS, Maximo, LIMS, MES
• Experience in managing multiple, competing priorities in a fast-paced environment
• Experience leading and/or managing teams
• Direct bulk drug substance and drug product experience
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
• Ability to solve complex problems and make scientific risk-based decisions
• Experience representing Amgen while interacting with representatives of regulatory agencies
• Experience of trending analysis
• Demonstrated proficiency using Excel, Word and Power Point

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.

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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.