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Sr Associate QA

3 months ago

Holly Springs, Georgia, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Associate Quality Assurance

Live

What you will do

Let's do this. Let's change the world. In this vital role you will be a part of our Amgen North Carolina Quality Assurance team. The role will support the inspection, sampling, and to perform Raman Spectroscopy testing of raw materials that are received at the Amgen North Carolina site. This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process. This role will also demonstrate leadership skills in support of scheduling, coordination, and staff training. There will be opportunities to advance Quality learning through additional responsibilities and training.

  • Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met
  • Perform sampling from containers of medias and other chemicals to facilitate the testing of samples
  • Use RAMAN technology with TruScan equipment to identify chemicals
  • Ensure that inspection & sampling results are complete and detailed according to written procedures and cGMP requirements
  • Responsible for accurately detailing inspection, sample, and test results in Amgen's systems
  • Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures
  • Ability to determine the color and appearance of components match required attributes
  • Leads/Participates in inspections/walkthroughs to ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP regulations and other safety standards.
  • Oversee the warehouse's quality assurance, which encompasses managing quality documentation such as deviations/CAPAs, change controls, and work orders, ensuring compliance with procedural standards, and verifying that evaluations and assessments of various partners are detailed and precise.
  • Support inspection readiness activities including site audits and inspections
  • Maintains project plan commitments supporting critical projects
  • Leads and Supports Continual Improvement initiatives, programs and projects
  • Serve as a shift lead in the raw material inspection and sampling areas
  • Assist area management with the prioritization and scheduling of tasks
  • Serve as a trainer and subject matter expert in tasks associated with raw material inspections, samples, and testing
  • Author, own, review and approve controlled documents for the area including SOPs and FORMs
  • Initiate, and own deviation records and CAPAs associated with events and projects in ANC's raw material inspections, samples and testing areas

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The quality assurance professional we seek is a leader with these qualifications.

Basic Qualifications:

  • High school diploma / GED and 4 years of cGMP inspecting and/or sampling experience OR
  • Associate's degree + 2 years of cGMP inspecting and/or sampling experience OR
  • Bachelor's degree + 6 months of cGMP inspecting and/or sampling experience OR
  • Master's Degree

Preferred Qualifications:

  • Strong understanding of cGMP regulations and GDP requirements
  • SAP, LIMs, and TrackWise experience
  • Experience with RAMAN technology
  • Experience as a Trainer in raw material inspections, sampling, and testing
  • Ability to lift and perform physical activities with raw materials
  • Strong written and verbal communication skills

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.