Amgen Jobs

This person assumes primary responsibility for execution of quality systems such as deviation process, procedures, change request, and corrective actions. Apply process operational scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support Louisville Distribution Center (LDC) Warehouse and Distribution Operations. The Specialist Supply Chain serves as a document owner, initiate, review, revise and approve deviations, change request and SOPs. The individual ensures all procedures reflect current operations and improves the quality and performance of the LDC Operations by identifying and implementing (continuous) improvements initiatives. The person provides support to warehouse operations Business Process Owners on related projects, non-conformances, triage activities, and business support activities.

Primary objectives:

• Work within full GMP compliance

• Own Deviations, CAPAs, CAPA-EVs and Change records

• Perform (comprehensive) Deviations and CAPA actions

• Generates Quality Records monthly metrics

• Lead Quality Records weekly meetings

• Generates change control records

• Effectively manage CAPA and Change implementation plans

• Ensure timely closure of owned records

• Develop, revise, and maintain operations related (GMP) documentation (SOPs and FORMs).

• Help to ensure integrity of available data

• Participate in continuous improvements initiatives

• Perform Risk-Based Decisions analyses as part of LDC risk management initiatives

• Become actively involved when required to resolve complex operational issues

• Participate in inspections audits from regulatory agencies and internal auditors

• Maintain compliant training records

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 2 years of experience OR

• Bachelor’s degree and 4 years of experience OR

• Associate’s degree and 10 years of experience OR

• High school diploma / GED and 12 years of experience

Preferred Qualifications:

• Understanding of industry requirements (GMP, GDP)

• Ability to liaise/communicate effectively and easily with cross-functional teams and different cultures

• Proven troubleshooting, problem solving and investigational skills.

• Experienced with data diagnostics, discovery, modeling, and visualization (i.e., Tableau, Excel)

• Excellent written and oral communication skills

• Fluency in English, written and verbal

• Must be a team player that is willing lead, work in and embrace a team environment

• High personal integrity

Systems:

• Deviation/CAPA (TrackWise)

• CCMS

• CDOCS-Quality

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.