Sr Associate Quality Control I

Amgen Inc.; Holly Springs (NC); On-site; USD 79,000 - 107,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary bonus

Stock-based incentives

Paid time off

Flexible work models

Job summary

Amgen Inc. in Holly Springs, NC, seeks a SR Associate Quality Control I to join the QAQC team. You will support the Chemistry lab startup, qualification, and routine testing to back our Holly Springs facility, writing procedures and validating systems.

The role requires hands-on QC chemistry experience in GMP settings, with emphasis on method transfers, data integrity, and collaboration across departments. Eligible candidates should have strong communication skills and readiness for diverse lab

Qualifications

• 4+ years of relevant laboratory experience in GMP commercial manufacturing environment.
• Strong knowledge of laboratory techniques.
• Experience with equipment validation, transfer and method validation including change controls.

Responsibilities

• Support Chemistry lab startup and qualification activities, including equipment installation, qualification, and validation.
• Write procedures and reports; assist with data integrity assessments and computerized system onboarding.
• Lead start-up activities for QC Chemistry, including system qualification and method transfer; support CAPA and change control processes.
• Collaborate with site teams to establish work orders and PM system for laboratory equipment; assist audits and cross-functional projects.

Skills

Lab techniques

Quality control

Documentation

Data integrity

Written communication

Education

Bachelor's degree in Chemistry/Biochemistry/Physics or Chemical Engineering

Tools

LIMS

LMES/CIMS

Job description

Career Category Quality Job Description 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.

SR ASSOCIATE QUALITY CONTROL I

What you will do

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

• Supporting the Chemistry lab start up and then performing qualification and routine testing to support the Holly Springs Facility.
• Writing procedures and reports, executing activities to support initial lab equipment installation, qualification, and validation.
• Method transfers and training development as well as support of implementation of computerized systems.
• Reporting directly to the Director of Quality Control.
• Being a subject matter expert on QC Chemistry Laboratory operations and testing.
• Supporting manufacturing operations, which may involve extended hours, shift and weekend work.
• Under minimal supervision, supporting the startup of the QC organization by: leading the QC Chemistry start up activities including system qualification and validation and method transfers.
• Working collaboratively with site teams to establish work order and PM system for laboratory equipment.
• Assisting with review of validation documents to support equipment and computerized system onboarding.
• Assisting with creating and collaborating on Data Integrity Assessments for computerized lab systems.
• Authoring, revising and reviewing documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, and technical assessments.
• Assisting with procurement activities for consumables and critical reagents for lab start up.
• Ensuring successful training and method transfer activities for HPLC, UPLC, TOC and other related Chemistry bench top Equipment.
• Owning and managing Deviation, CAPA and Change Control records to support Quality Control.
• Participating in audits, initiatives, and projects that may be interdepartmental or global in scope.
• Supporting routine activities over the weekends and public holidays as required.

What we expect of you

Basic Qualifications

High school/GED + 4 years of Quality work experience OR Associate’s + 2 years of Quality work experience OR Bachelor’s + 6 months of Quality work experience OR Master's

Preferred Qualifications

• Degree in a related scientific field such as Chemistry, Biochemistry, Physics or Chemical Engineering.
• 4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
• Strong knowledge of laboratory techniques.
• Proficient in the use of LIMS & LMES/CIMS.
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
• Strong written and verbal communication skills including technical writing and presentation.
• Experience with equipment and method validation, verification, and transfer including the change control process.
• Interact effectively with variety of communication and working styles and ability to work well in teams.

What you can expect of us

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.

Salary Range 78,724.45USD -106,509.55 USD

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.

Equal Opportunity Employer

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.

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.

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 since1980, 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