Job Information
Amgen Senior Associate Quality Assurance - Incoming Quality in Holly Springs, North Carolina
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.
careers.amgen.com