Career Category

Job Description

The Sr. Associate will be responsible for Quality On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.  This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff.  Amgen’s Quality Assurance On-the-Floor position Shift 5 (3 days a week Saturday through Monday 7pm – 7am) provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regards to compliance and quality systems. 

Responsibilities include the following:
 

Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing.

Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.

Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.

Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Nonconformance, Corrective Action/Preventative Actions (CAPA),

Author/review/approve quality documents, such as:  SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.

Establish and enable LEAN practices. 

Oversee and provide guidance during on-the-floor analytical testing.

Ensures that deviations from established procedures are investigated and documented per procedures.

Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

Alerts senior management of quality, compliance, supply and safety risks.

Completes required assigned training to permit execution of required tasks.

Drive operational improvement initiatives, programs and projects.

Basic Qualifications

Master’s degree
OR
Bachelor’s degree and 2 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
OR
Associate’s degree and 6 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
OR
High school diploma / GED and 8 years of Quality, Manufacturing, Validation, 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 investigations and quality systems process knowledge

Experience and training in CDOCS, Trackwise, Maximo, LIMS

Experience in managing multiple, competing priorities in a fast-paced environment

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 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.

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.