Sr Associate Supply Chain Compliance

Amgen • Louisville, KY

1d

About The Position

The Sr Associate Supply Chain Compliance serves as a key compliance partner within the US and LACAN Supply Chain, safeguarding product quality and patient trust through effective implementation of Good Distribution Practice (GDP) requirements, quality systems, and regulatory standards. The role leads critical quality processes, identifies and mitigates risks, and drives operational excellence across the distribution network.

The position supports inspection readiness, audits and inspections, product recall and mock recall activities, and continuous improvement. It manages records and reports relating to temperature assessments, deviations, CAPAs, missing product notifications, and periodic evaluations.

Requirements

• Master’s degree; or bachelor’s degree and 2 years of GMP/GDP compliance experience; or associate’s degree and 6 years of GMP/GDP compliance experience; or high school diploma/GED and 8 years of GMP/GDP compliance experience.

Nice To Haves

• Sound knowledge of Quality Assurance principles, Good Manufacturing Practice, and Good Distribution Practice.
• Fluency in English.
• Technical writing skills.
• Strong word-processing, database, and spreadsheet application skills, and experience with Quality Management Software systems such as Veeva or SAP.
• Experience in deviation management and audit/inspection support.
• Effective communication skills across multiple levels, areas, and countries.
• Ability to apply a risk-based approach, make decisions, and escalate issues appropriately.
• Analytical and evidence-based approach to problems.
• Ability to recognize connections between issues, identify common factors, and bring the appropriate stakeholders together.

Responsibilities

• Own and manage temperature assessment records.
• Own and manage minor and major deviation records and lead root cause analysis sessions.
• Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.
• Manage missing product notifications, including leading Event Review Team meetings when applicable.
• Support inspection readiness activities and audits and inspections involving the US and LACAN Supply Chain.
• Manage and own Periodic Evaluation reports.
• Support product recall activities or annual mock recall exercises.
• Keep daily management sheets up to date for minor and major deviations, temperature excursions, and missing product events.
• Support continuous improvement activities.
• Keep spreadsheets up to date for minor and major deviations, temperature excursions, and missing products.

Benefits

• Comprehensive employee benefits package.
• Retirement and Savings Plan with company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Time-off plans.
• Flexible work models where possible.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed