Sr Associate QA - Nights

BioSpace; West Greenwich (RI); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen seeks a Sr Associate QA- Nights to support on-the-floor manufacturing operations. You will provide quality oversight for cGMP compliance, review batch records, and collaborate with Manufacturing, Quality Control, and Facilities/Engineering to ensure real-time quality decisions.

This role requires rotating 12-hour shifts (7 PM–7 AM) with weekend rotation and a 15% shift differential; candidates should have QA/manufacturing experience and education per the basic qualifications.

Qualifications

• Bachelor's or higher degree in a related field or equivalent combination of education and experience.
• 4+ years QA or manufacturing experience for High School/GED path or 1+ year with a Bachelor’s.
• Experience in a cGMP environment preferred.
• Experience with batch records and GMP documentation is desirable.

Responsibilities

• Provide QA oversight to ensure products are manufactured, tested, stored, and distributed per cGMP/GDP and applicable regs.
• Oversee on-the-floor analytical testing and real-time quality decision-making.
• Ensure facilities, equipment, materials, processes, and procedures follow cGMP and regulatory requirements.
• Investigate and document deviations from procedures per written SOPs and cGMP.
• Review and approve cGMP processes, procedures, records, SOPs, batch records, deviations, and logbooks.
• Author and approve quality documents such as risk assessments and training materials.
• Escalate potential quality, compliance, or safety risks to senior management.
• Complete required training and drive continuous improvement initiatives.

Skills

Quality Assurance

Analytical thinking

Cross-functional collaboration

Education

High School/GED

Associates

Bachelors

Master's

Tools

Microsoft Office

Excel

PowerPoint

MS Teams

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.

Sr Associate QA- Nights

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for Plant Quality Assurance (PQA) On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff, and also to provide coaching, guidance and direction to Manufacturing, Quality Control, and Facilities/Engineering staff regarding compliance and quality systems.

Responsibilities Include

• Provide Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.
• Provide Quality oversight during on-the-floor analytical testing.
• Ensure that facilities, equipment, materials, processes, and procedures follow cGMPs and other applicable regulations.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Perform review and approval of cGMP processes, procedures, and records, including but not limited to, Standard Operating Procedures (SOPs), batch records, deviations, and logbooks.
• Author, review, and approve quality documents such as risk assessments, training materials, engineering documents, automation documents, protocols, and reports.
• Alert senior management of potential quality, compliance, supply, or safety risks.
• Complete assigned training to permit execution of required tasks.
• Drive operational improvement initiatives, programs, and projects.
• Perform other tasks, as assigned, to assist in completion of activities associated with meeting group, departmental, and company goals

In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (C shift). The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off and receiving an added 15% shift differential.

What we expect of you

We are all different, yet we all use your unique contributions to serve patients. The agile professional we seek is a good collaborator with these qualifications.

Basic Qualifications

• High school/GED + 4 years Quality Assurance or manufacturing work experience OR
• Associates + 2 years Quality Assurance or manufacturing work experience OR
• Bachelors + 6 months Quality Assurance or manufacturing work experience
• Master's

Preferred Qualifications

• Experience working in a cGMP environment
• Experience with decision making
• Experience with analytical testing and/or general compendia testing

Experience Working With Batch Records And Other GMP Documentation

• Knowledge of data integrity requirements
• Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS 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, 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.