Associate Quality Control HPLC / CE

Amgen Foundation, Inc.; Thousand Oaks (CA); Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Competitive benefits

Total Rewards Plan

Flexible work model

Zusammenfassung

Amgen Inc. is seeking an Associate Quality Control professional to support the QC analytical chemistry team performing HPLC/UHPLC, CE, and related techniques in a GMP environment. You will contribute to testing, data integrity and method documentation.

Under supervision you will document results, maintain equipment, and help implement new methods. A Bachelor’s or equivalent with familiarity in cGMPs and analytical methods is required, with strong attention to detail and communication.

Qualifikationen

• 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 with HPLC and/or Capillary Electrophoresis techniques preferred
• Ability to adhere to regulatory requirements, written procedures and safety guidelines

Aufgaben

• 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.

Kenntnisse

Attention to detail

Communication skills

Regulatory compliance understanding

Ausbildung

Bachelor’s degree or Associate’s degree

Tools

HPLC

Capillary Electrophoresis (CE)

cGMP knowledge

Jobbeschreibung

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 lay 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 HPLC/CE

What you will do

Let’s do this. Let’s change the world.

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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

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 escalatte

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• 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. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.