Associate Quality Control HPLC/CE
Amgen
Summary
The Associate Quality Control will support the QC analytical chemistry team by performing testing HPLC/UHPLC (high and ultra-high liquid chromatography), titer, CE (capillary electrophoresis), CEX (cation exchange), HILIC (hydrophilic interaction). This role may also perform additional testing such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH.
Job description
What you will do
The Associate Quality Control will support the QC analytical chemistry team by performing testing HPLC/UHPLC (high and ultra-high liquid chromatography), titer, CE (capillary electrophoresis), CEX (cation exchange), HILIC (hydrophilic interaction). This role may also perform additional testing such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH.
Under general supervision, this position is responsible for performing analytical testing and support in the HPLC/Capillary Electrophoresis (CE) group in Clinical Quality Control.
Responsibilities include:
- Responsible for one or more of the following activities in QC: analytical testing, sample and data management and equipment maintenance.
- Perform routine laboratory procedures such as sample analysis, standard and solution preparation.
- Responsible for documenting, compiling, interpreting, reviewing and entering laboratory data.
- Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports.
- Support introduction of new methods/techniques into the lab.
- Perform basic assay and instrument troubleshooting.
- May identify, recommend and implement improvements related to routine job functions.
- Must learn and align with safety guideline and basic cGMPs
- Must be flexible in working schedule as required
- Must be able to be on-call for CEMS as required
Basic Qualifications:
Bachelor's degree OR Associate's degree and 6 months of Quality Control, Quality Assurance or related experience OR High school diploma / GED and 2 years of Quality Control, Quality Assurance or related experience
Preferred Qualifications:
- Experience in HPLC and/or Capillary Electrophoresis techniques
- Ability to adhere to regulatory requirements, written procedures and safety guidelines
- Ability to evaluate documentation/data according to company and regulatory guidelines
- Ability to organize work, handle multiple priorities and meet deadlines
- Strong written and oral communication skills
- Must be detail orientated
- Must be flexible and adaptable to changing priorities and requirements
- Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance
- Demonstrate understanding of when and how to appropriately escalate
Requirements
- Bachelor's degree OR Associate's degree and 6 months of Quality Control, Quality Assurance or related experience OR High school diploma / GED and 2 years of Quality Control, Quality Assurance or related experience
- Experience in HPLC and/or Capillary Electrophoresis techniques
- Ability to adhere to regulatory requirements, written procedures and safety guidelines
- Ability to evaluate documentation/data according to company and regulatory guidelines
- Ability to organize work, handle multiple priorities and meet deadlines
- Strong written and oral communication skills
- Detail oriented
- Flexible and adaptable to changing priorities and requirements
- Understanding of regulatory requirements, safety guidelines and factors impacting compliance
- Understanding of when and how to appropriately escalate
Benefits
- Health Insurance
- Dental Coverage
- Vision Coverage
- Life Insurance
- Disability Insurance
- Retirement and Savings Plan
- Flexible Spending Accounts
- Annual Bonus Program
- Stock-Based Long-Term Incentives
- Paid Time-Off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.