Specialist QC

Initial Therapeutics, Inc.; West Greenwich (RI); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Time-off plans

Flexible work models

Job summary

Amgen is seeking a Specialist QC to support analytical investigations within the QC Technical Services team. You will lead investigations for OOS, OOT, and atypical results, performing root cause analysis and implementing CAPAs.

You will own deviations, change controls, and effectiveness verifications, collaborating with Quality, Manufacturing, and QA to ensure risk-based outcomes and inspection readiness. Excellent communication is essential in this cross-functional role.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or Life Science discipline.
• 58+ years of Quality Control or Quality Assurance experience in biotech/pharma.
• Experience leading complex laboratory investigations (OOS, OOT, atypical results).
• Strong GMP knowledge and deviation management experience.
• Experience performing root cause analysis using structured methods.

Responsibilities

• Lead QC analytical investigations for OOS, OOT, atypical results and other investigations.
• Perform root cause analysis and develop CAPAs.
• Own deviations, CAPAs, and change controls; support risk-based decisions.
• Collaborate with QC laboratories, Manufacturing, Process Development, QA, Supply Chain and other groups.
• Maintain inspection-ready documentation and support audits.

Skills

Analytical investigations

Root cause analysis

CAPA development

GMP compliance

Documentation

Cross-functional collaboration

Inspection readiness

Education

Bachelor's in Chemistry/Biochemistry/Biology/Pharmaceutical Sciences

Master's or Doctorate in Life Sciences

Tools

Laboratory instrumentation

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. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Specialist QC

What you will do

Lets do this. Lets change the world. In this vital role you will support analytical investigations ownership within the QC Technical Services team at Amgen.

Responsibilities:

Analytical Investigation Ownership

• Lead Quality Control analytical investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), atypical, and unexpected analytical results.
• Perform scientifically sound root cause analysis and develop effective corrective and preventive actions (CAPAs).
• Ensure investigations are completed accurately, on time, and in compliance with GMP requirements and internal quality standards.

Quality Systems & Risk Assessment

• Own and support deviations, CAPAs, and effectiveness verifications as assigned.
• Review and approve equipment-related change controls, as applicable.
• Partner with Quality Assurance to ensure investigation outcomes are risk-based and inspection-ready.
• May support additional project-based assignments as required.

Cross-Functional Collaboration

• Collaborate with Quality Control laboratories, Manufacturing, Process Development, Quality Assurance, Supply Chain, and other functional groups to resolve complex quality events.
• Facilitate effective communication among stakeholders to ensure timely investigation progression and issue resolution.
• Engage subject matter experts as needed to support technically complex investigations.

Inspection Readiness

• Support internal and external audits by clearly communicating investigation findings, root cause, and CAPA effectiveness.
• Maintain complete, accurate, and inspection-ready documentation.

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 a collaborative teammate with these qualifications.

Basic Qualifications

• High school diploma/GED and 10 years of directly related experience OR
• Associate's degree and 8 years of directly related experience OR
• Bachelor's degree and 4 years of directly related experience OR
• Master's degree and 2 years of directly related experience OR
• Doctorate degree

Preferred Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or another Life Science discipline.
• 58+ years of Quality Control or Quality Assurance experience within the biotechnology or pharmaceutical industry.
• Demonstrated experience leading complex laboratory investigations, including OOS, OOT, atypical results, and laboratory deviations.
• Strong knowledge of GMP regulations, laboratory quality systems, and deviation management processes.
• Experience performing root cause analysis using structured problem-solving methodologies.
• Strong understanding of analytical laboratory techniques, instrumentation, and data integrity principles.
• Experience authoring and managing deviations, CAPAs, change controls, and effectiveness verifications.
• Ability to evaluate technical data, assess risk, and make sound, science-based decisions.
• Strong written and verbal communication skills with the ability to influence cross-functional teams.
• Experience supporting regulatory inspections and responding to auditor inquiries.
• Experience utilizing digital tools, data analytics, or AI-enabled technologies to improve laboratory processes is preferred.

What you can expect from 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.

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 diverse, 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 and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.