Associate Quality Control HPLC/CE
About The Position
The Associate Quality Control HPLC/CE supports Amgen’s Clinical Quality Control analytical chemistry team by performing laboratory testing using HPLC/UHPLC, titer, CE, CEX, and HILIC methods. The role may also involve TOC, LAL, protein concentration, appearance, and pH testing. Under general supervision, the position performs analytical testing and provides support to the HPLC/Capillary Electrophoresis group. The Associate is responsible for activities that may include analytical testing, sample and data management, and equipment maintenance. The role includes routine laboratory procedures, preparation and review of laboratory documentation and data, communicating results, operating specialized equipment, drafting and revising methods and technical documents, supporting new method introduction, and troubleshooting assays and instruments. The position requires learning and following safety guidelines and basic cGMPs, flexibility in work schedule, and availability for CEMS on-call duties as required.
Requirements
- Bachelor’s degree; alternatively, an Associate’s degree and 6 months of Quality Control, Quality Assurance, or related experience; or a high school diploma/GED and 2 years of Quality Control, Quality Assurance, or related experience.
- Ability to follow regulatory requirements, written procedures, and safety guidelines.
- Ability to evaluate documentation and data according to company and regulatory guidelines.
- Ability to organize work, manage multiple priorities, and meet deadlines.
- Strong written and oral communication skills.
- Attention to detail.
- Flexibility and adaptability to changing priorities and requirements.
- Understanding of regulatory requirements, safety guidelines, and factors impacting compliance.
- Understanding of when and how to escalate appropriately.
- Flexibility in working schedule as required and ability to be on-call for CEMS as required.
Nice To Haves
- Experience with HPLC and/or capillary electrophoresis techniques.
Responsibilities
- Perform analytical testing using HPLC/UHPLC, titer, CE, CEX, and HILIC; may also perform TOC, LAL, protein concentration, appearance, and pH testing.
- Perform QC activities such as analytical testing, sample and data management, and equipment maintenance.
- Conduct routine laboratory procedures, including sample analysis and preparation of standards and solutions.
- Document, compile, interpret, review, and enter laboratory data.
- Communicate results and maintain and operate specialized equipment.
- Draft and revise analytical methods, SOPs, and technical reports.
- Support the introduction of new methods and techniques into the laboratory.
- Perform basic assay and instrument troubleshooting.
- Identify, recommend, and implement improvements related to routine job functions when appropriate.
- Learn and follow safety guidelines and basic cGMPs.
- Work a flexible schedule as required and be available for CEMS on-call duties as required.
Benefits
- Retirement and Savings Plan with company contributions
- Medical insurance
- Dental insurance
- Vision coverage
- Life insurance
- Disability insurance
- Flexible spending accounts
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
