VetJobs
Specialist Supply Chain Compliance - Louisville, KY
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Specialist Supply Chain Compliance
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VetJobs
Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On‑Site" at the location detailed in the job post.
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease— we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lay within, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What You Will Do
Own and manage deviations, trend investigations records, CAPA and CAPA EV records; lead root cause analysis sessions.
Own and manage the trend trigger and periodic evaluation report for temperature excursions and distribution complaints.
Provide training sessions related to SC Compliance.
Act as Subject Matter Expert (SME) for Quality Systems Deviation, CAPA, CAPA EV, Temperature excursion, Distribution Complaint and Periodic monitoring.
Participate in and support inspection readiness activities, audits and inspections.
Deploy new (global) capabilities and projects as appropriate.
Support change management and operational excellence initiatives to improve process compliance performance.
Author and own documents (procedures, forms, manuals, training materials, etc.) for the SC Compliance team.
Lead Event Review meetings for missing product events.
Perform data analysis for Management reviews of the quality system on a periodic basis.
Incidentally own and manage temperature excursion records of products.
Provide guidance/direction in all areas of GDP and FMD.
Management Responsibilities
Responsible for hiring, training, supervising, coaching and performance management of SC Compliance staff.
Minimum Education Required
High School/GED
Basic Qualifications
Doctorate degree
OR Master’s degree and 2 years of Supply Chain experience
OR Bachelor’s degree and 4 years of Supply Chain experience
OR Associate’s degree and 8 years of Supply Chain experience
OR High school diploma / GED and 10 years of Supply Chain experience
Preferred Qualifications
Experience in audit/inspection support
Technical writing skills
Benefits
Comprehensive employee benefits package, including retirement and savings plan with company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
Discretionary annual bonus program; field sales incentive plan for applicable roles.
Stock‑based long‑term incentives.
Award‑winning time‑off plans.
Flexible work models where possible.
Salary Range 107,333.00 USD - 137,857.00 USD
Location Louisville, KY
Employment Type Full‑time
Seniority Level Mid‑Senior level
Job Function Management and Manufacturing
Referral Information Referrals increase your chances of interviewing at VetJobs by 2x
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Contact Get notified about new Supply Chain Specialist jobs in Louisville, KY.
#J-18808-Ljbffr
Specialist Supply Chain Compliance
role at
VetJobs
Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On‑Site" at the location detailed in the job post.
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease— we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lay within, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What You Will Do
Own and manage deviations, trend investigations records, CAPA and CAPA EV records; lead root cause analysis sessions.
Own and manage the trend trigger and periodic evaluation report for temperature excursions and distribution complaints.
Provide training sessions related to SC Compliance.
Act as Subject Matter Expert (SME) for Quality Systems Deviation, CAPA, CAPA EV, Temperature excursion, Distribution Complaint and Periodic monitoring.
Participate in and support inspection readiness activities, audits and inspections.
Deploy new (global) capabilities and projects as appropriate.
Support change management and operational excellence initiatives to improve process compliance performance.
Author and own documents (procedures, forms, manuals, training materials, etc.) for the SC Compliance team.
Lead Event Review meetings for missing product events.
Perform data analysis for Management reviews of the quality system on a periodic basis.
Incidentally own and manage temperature excursion records of products.
Provide guidance/direction in all areas of GDP and FMD.
Management Responsibilities
Responsible for hiring, training, supervising, coaching and performance management of SC Compliance staff.
Minimum Education Required
High School/GED
Basic Qualifications
Doctorate degree
OR Master’s degree and 2 years of Supply Chain experience
OR Bachelor’s degree and 4 years of Supply Chain experience
OR Associate’s degree and 8 years of Supply Chain experience
OR High school diploma / GED and 10 years of Supply Chain experience
Preferred Qualifications
Experience in audit/inspection support
Technical writing skills
Benefits
Comprehensive employee benefits package, including retirement and savings plan with company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
Discretionary annual bonus program; field sales incentive plan for applicable roles.
Stock‑based long‑term incentives.
Award‑winning time‑off plans.
Flexible work models where possible.
Salary Range 107,333.00 USD - 137,857.00 USD
Location Louisville, KY
Employment Type Full‑time
Seniority Level Mid‑Senior level
Job Function Management and Manufacturing
Referral Information Referrals increase your chances of interviewing at VetJobs by 2x
Other Related Positions
Logistics and Inventory Control Coordinator
Logistics Coordinator - Retail Activations, Fabletics (Louisville, KY)
Supply Chain Operations Specialist, Warehouse, Days
Shipping & Receiving Coordinator- A Crew
Material Control Specialist II, Planning Material Center
Shipping & Receiving Coordinator- B Crew
Shipping & Receiving Coordinator- C Crew
SAP Supply Chain/Logistics Manager - Retail
Contact Get notified about new Supply Chain Specialist jobs in Louisville, KY.
#J-18808-Ljbffr