Associate QC I

Amgen Inc.; Holly Springs (NC); On-site; USD 63,000 - 85,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Medical/dental/vision coverage

Retirement plan

Job summary

Amgen Inc. in Holly Springs, NC, is seeking an Associate QC I to support the Chemistry lab start-up, qualification, and routine testing. You will help with system qualification, method transfers, data integrity, and GMP compliance while collaborating with cross-functional teams.

The role may require extended hours and weekend work as needed; a strong background in analytical chemistry and GMP manufacturing is essential for success.

Qualifications

• 4+ years lab experience in GMP pharma/manufacturing with analytical testing.
• Strong knowledge of laboratory techniques.
• Proficient with LIMS/LMES/CIMS.
• Familiar with regulatory and compliance issues.
• Strong written and verbal communication, technical writing.
• Experience with method validation, verification and transfers.
• Ability to work well in cross-functional teams.

Responsibilities

• Participate in QC Chemistry start-up activities including system qualification/validation and method transfers.
• Collaborate with site teams to establish work orders and PM for lab equipment.
• Assist with Data Integrity Assessments for computerized lab systems.
• Review and approve QC method executions for GMP and stability support.
• Assist with procurement of consumables and reagents.
• Ensure execution of method transfer for HPLC, UPLC, TOC and related equipment.
• Support audits, initiatives, and interdepartmental projects.
• Support weekend and holiday work as required.

Skills

GMP manufacturing experience

Analytical testing

Laboratory techniques

LIMS/LMES/CIMS

Communication skills

Education

Bachelor's degree in a related scientific field

Associate degree or higher

Tools

HPLC/UPLC

TOC

Lab equipment and instrumentation

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.

ASSOCIATE QC I

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for supporting the Chemistry lab start up and then performing qualification and routine testing to support the Holly Springs Facility. Responsibilities will include 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. The Senior Associate QC Chemistry will initially report directly to the Director of Quality Control. This individual will be a subject matter expert on QC Chemistry Laboratory operations and testing. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary. Under minimal supervision, the successful candidate will support the startup of the QC organization by:

• Participating in the QC Chemistry start up activities including execution of system qualification and validation and method transfers.
• Working collaboratively with site teams to establish work order and PM system for laboratory equipment.
• Assisting with creating and collaborating on Data Integrity Assessments for computerized lab systems.
• Review and Approve QC method executions for GMP and Stability support.
• Assisting with procurement activities for consumables and critical reagents for routine lab activities.
• Ensure execution and method transfer activities for HPLC, UPLC, TOC and other related Chemistry bench top Equipment.
• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
• Support routine activities over the weekends and public holidays as required.

What we expect of you

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

Basic Qualifications:

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

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.

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.

Salary Range 62,571.90USD -84,656.10 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