Senior Associate Quality Control - Days

BioSpace; West Greenwich (RI); On-site; USD 85,000 - 110,000; Full time

Job summary

Amgen is seeking a Senior Associate Quality Control to perform rigorous analytical testing (HPLC, GC, GC-MS) and data review in a fast-paced environment. The role emphasizes adherence to cGMP, accurate documentation, and participation in investigations and audits.

You will support training and continual improvements while ensuring product quality and regulatory readiness. The successful candidate will work with state-of-the-art instrumentation, collaborate with cross-functional teams, and

Qualifications

• Experience with analytical testing per compendia and methods.
• Strong ability to generate and review laboratory documentation.
• Familiarity with regulatory inspections and cGMP practices.

Responsibilities

• Perform testing using HPLC, GC, GC-MS.
• Analyze data for routine and non-routine procedures.
• Maintain and operate laboratory equipment.
• Update procedures, records andCAPAs as required.
• Support investigations, audits and safety compliance.
• Assist training of new staff and ensure regulatory readiness.

Skills

HPLC

GC

GC-MS/ICP-MS

Team leadership

cGMP knowledge

Education

Bachelor's Degree in Chemistry/Related Field

4 years Quality experience

Tools

QC analytical systems

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate Quality Control

What you will do

Lets do this. Lets 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.

Responsibilities Include

• 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

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, well 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.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.