Senior Associate Quality Control - Days

Amgen; West Greenwich (RI); On-site; USD 79,000 - 107,000; Full time

Job summary

Amgen in Rhode Island is seeking a Senior Associate Quality Control to perform analytical testing using HPLC, GC and GC-MS, manage data and operate essential lab instruments. The role requires familiarity with cGMP workflows, audits, and documentation practices in a fast-paced environment.

The ideal candidate has a relevant degree with QC experience and strong data integrity, communication, and teamwork skills to support continuous improvement and regulatory readiness.

Qualifications

• High school diploma/GED with 4 years QC experience
• Associate's degree with 2 years QC experience
• Bachelor's degree with 6 months QC experience
• Master's degree with QA experience

Responsibilities

• Perform testing methods including HPLC, GC and GC-MS
• Perform testing and data analysis for compendia, non-compendia methods, and routine laboratory procedures
• Perform routine and non-routine evaluations and data review
• Generate accurate and concise laboratory documentation using electronic systems and notebooks
• Operate and maintain specialized laboratory equipment and instrumentation
• Participate in laboratory investigations, inspections and audits
• Stay in sync with safety guidelines, cGMPs and other applicable regulatory requirements
• Support training of new staff as applicable
• Ensure facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations
• Perform review and approval of procedures, assays, documents and records, including deviation records and CAPAs
• Alert management of quality, compliance, supply and safety risks
• Completes required training to permit completion of tasks
• Support Continual Improvement initiatives, programs and projects
• Ensure changes that could potentially impact product quality are assessed according to procedures

Skills

HPLC

GC

GC-MS

ICP-MS

Lab testing

GxP knowledge

Data analysis

Documentation

Audits

Team leadership

Education

Bachelor's Degree

Associate's Degree

Master's Degree

Tools

Laboratory instrumentation

Electronic lab notebook

QA systems

Job description

Senior Associate Quality Control

What you will do Let’s do this. Let’s change the world. In this vital role, under minimal supervision, you will be responsible for activities including Raw Material testing using sophisticated instrumentation, such as HPLC, GC and GC-MS, sample/data management and equipment/instrumentation operation and maintenance in a highly dynamic, team environment.

• Perform testing methods including HPLC, GC and GC-MS
• Perform testing and data analysis for compendia, non-compendia methods, and routine laboratory procedures
• Perform routine and non-routine evaluations and data review
• Generate accurate and concise laboratory documentation using electronic systems and notebooks
• Operate and maintain specialized laboratory equipment and instrumentation
• Participate in laboratory investigations, inspections and audits
• Stay in sync with safety guidelines, cGMPs and other applicable regulatory requirements
• Support training of new staff as applicable
• Ensure facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations
• Perform review and approval of procedures, assays, documents and records, including but not limited to deviation records and CAPAs
• Alert management of quality, compliance, supply and safety risks
• Completes required assigned training to permit completion of required tasks
• Support Continual Improvement initiatives, programs and projects.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is detail oriented with these qualifications.

Basic Qualifications:

High school diploma/GED and 4 years of Quality experience OR Associate's degree and 2 years of Quality experience OR Bachelor's Degree and 6 months of Quality experience OR Master's Degree

Preferred Qualifications:

• Experience in HPLC, GC, ICP-MS and/ or GC-MS
• Demonstrated laboratory technique with pipetting small volumes accurately
• Professional work experience in a fast-paced, flexible GxP laboratory
• Experience executing analytical testing per Methods and/or Compendia
• Experience with QC analytical systems and/or Quality systems
• Excellent interpersonal, written and verbal communication skills with all levels within the organization
• Ability to work in a team matrix environment and build relationships with partners
• Experience leading teams or projects
• Identify, manage, and champion innovative projects to advance productivity and enable LEAN principles across different functions
• Experience in auditing and defending processes, procedures and decisions during regulatory inspections
• Demonstrated innovative thinking and ability to transform work organizations
• Strong communication skills (technical writing and oral), facilitation and presentation skills
• Exposure to Operational Excellence initiatives
• Demonstrated ability to navigate through ambiguity and provide a structured problem solving
• Demonstrated ability to deliver on schedule.

What you can expect of us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

• 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.

Salary Range

Salary Range 78,724.45USD -106,509.55 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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.