Associate Quality Control- Incoming

Amgen • Juncos, PR

1d

About The Position

Join Amgen’s Mission of Serving Patients 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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Associate Quality Control - Incoming What you will do Let’s do this. Let’s change the world. In this vital role the successful candidate will work with a team responsible for the Incoming Quality Control sampling and inspection processes of primary/secondary components, devices and raw materials. In addition, will be responsible for raw material sample shipments, testing and batch record's review per standard operating procedures and guidelines. Will also work cross-functionally to support multiple customers and stakeholders including Supply Chain, Quality Assurance, Process Development, Engineering and Quality Control.

Requirements

• High school/GED + 2 years of work experience in Quality Control OR Associate’s + 6 months of work experience in Quality Control OR Bachelor’s degree
• Basic knowledge and experience in sampling and inspection processes for raw material, components, drug substance, drug product and devices per procedures and regulations.
• Strong verbal and written communication skills
• Intermediate proficiency with Microsoft Office (Word, Excel, PowerPoint, databases)
• Strong time management and task prioritization skills in a fast-paced environment
• Good communication skills and presentation skills, (both written and verbal).
• Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously.
• Commitment to Amgen’s values and a quality-first culture

Nice To Haves

• Ishihara certification
• Educational background in Life Sciences or Engineering
• Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines
• Strong skills in systems such as SAP/ERP, eBR, LIMS, Trackwise, Coldstream, Veeva and applications such as Smartsheet among others
• Problem-solving approach with the ability to support investigations and recommend improvements
• Flexibility to support non-standard shifts, including weekends

Responsibilities

• Complete onboarding and all required training qualifications.
• Perform routine sampling and inspection of raw materials, components, drug substances/products, devices, and printed materials.
• Collaborate with Supply Chain Procurement, QA, Dispensing, Receiving, Shipping, and Packaging teams to ensure daily warehouse operations are well coordinated between each function.
• Operate laboratory equipment such as Optical Comparator, Keyence, Instron, TruScan and NIR for testing and inspection tasks.
• Use computer systems (e.g., LIMS, OEFM, SAP) to manage sample testing, document results, and support related activities.
• Evaluate test results in accordance with established SOPs and analytical methods.
• Review electronic batch record documentation for incoming raw materials and components.
• Identify and recommend process improvements for routine functions; implement changes upon approval.
• Troubleshoot process and/or testing issues in compliance with SOPs and escalate when necessary.
• Participate in regulatory inspections and internal/external audits.
• Perform cleaning and sanitization of classified areas and prepare disinfectant solutions.
• Train and qualify new staff to ensure consistent performance of assigned tasks.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED