Specialist QA 1

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 104,000 - 141,000; Full time

Job summary

Amgen Inc. (IR) in the United States seeks a Quality Assurance Specialist to oversee cGMP/ GDP compliance during bulk drug substance operations. You will collaborate with Manufacturing, Quality Control, Supply Chain and Facilities to ensure quality standards and documentation are met.

The role requires comprehensive knowledge of quality systems, regulatory expectations, and strong communication. Amgen offers opportunities for professional growth, competitive compensation, and a robust benefits

Qualifications

• High school diploma / GED or higher with relevant QA/Manufacturing experience
• Prefer degree in Life Science or Engineering for advanced roles
• Experience with cGMP biotech manufacturing in multi-product environment is advantageous
• Experience participating in health authority inspections and audits
• Strong organizational skills and excellent written/verbal communication

Responsibilities

• Provide Quality oversight to ensure operations are manufactured, tested, stored, and distributed per cGMP and GDP
• Review and approve cGMP documents and records (BPRs, Deviations, CAPAs)
• Lead on-the-floor analytical testing oversight
• Ensure production records and test results meet procedural standards
• Identify and implement continuous improvement opportunities within processes and systems
• Support audits and regulatory inspections and liaise with authorities when needed

Skills

Root Cause Analysis

Organizational skills

Communication skills

Education

High school diploma / GED

Associate’s degree

Bachelor’s degree

Master’s degree

Doctorate degree

Tools

MES

Delta-V

PI data historian

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. 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, 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.

SPECIALIST QA 1

What you will do

Let’s do this. Let’s change the world. In this vital role you will serve as Quality Assurance Specialist responsible for Plant Quality Assurance (PQA). 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 and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. Amgen’s Quality Assurance Specialist provides coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems. Responsibilities include the following:

• Responsible for providing Quality oversight to ensure that Operations’ products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA)
• Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Alert senior management of quality, compliance, supply and safety risks.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
• Identification and implementation of continuous improvement opportunities within our processes and systems
• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality Assurance professional we seek is a Specialist with these qualifications.

Basic Qualifications

• High school diploma / GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience
• Associate’s degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience
• Bachelor’s degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience
• Master’s degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience
• Doctorate degree

Preferred Qualifications

• Educational background in Life Science or Engineering.
• Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations.
• Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition
• Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian)
• Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations.
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
• Experience participating in, managing, and responding to health authority inspections, partner and corporate audits.
• Strong organizational skills, including ability to follow assignments through to completion.
• Excellent written and verbal communication skills.

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 $xxx,xxx.00 to $xxx,xxx.00. 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 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.

Salary Range 104,287.35USD -141,094.65 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