QA Specialist

Amgen SA; New Albany (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

Discretionary annual bonus program

Stock-based long-term incentives

Flexible work models

Job summary

Amgen Ohio is expanding its Quality Operations team. The Specialist QA will lead cross-functional staff as a Subject Matter Expert, ensuring GMP compliance and directing daily manufacturing operations, approvals of deviations and final batch disposition.

We seek candidates with advanced science degrees and GMP/GCP experience, strong problem solving, and ability to interact with regulators. Competitive benefits and growth opportunities are offered.

Qualifications

• Doctorate or Master’s with 2+ years QA/Manufacturing experience.
• GMP/GCP knowledge and strong documentation skills.
• Ability to lead investigations and drive corrective actions.

Responsibilities

• Review and approve controlled documents incl. SOPs, validation protocols and reports.
• Provide quality oversight for records including deviations and CAPAs.
• Drive investigations and resolution of deviations; ensure compliant outcomes.
• Ensure activities align with GMP, safety and Amgen requirements.
• Own SOPs, forms and document control; ensure timely review and update.
• Provide quality oversight for manufacturing and batch disposition.

Skills

Quality oversight

GMP/GCP experience

Root cause analysis

Documentation control

Education

Doctorate degree

Master’s degree + QA/Manufacturing experience

Bachelor’s degree + QA/Manufacturing experience

Associate’s degree + QA/Manufacturing experience

High school diploma/GED + QA/Manufacturing experience

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

What you will do

Let’s do this. Let’s change the world. In this role you will have the opportunity to be part of the continued expansion of Quality Operations at Amgen Ohio (AOH) supporting our growing state-of-the-art Final Drug Product (FDP) Plant. You will lead and direct cross functional staff as an informed Subject Matter Expert in the Quality deliverables. A key aspect of this role is to apply critical thinking skills to ensure quality and compliance to GMP regulations for operations and associated processes. Duties include oversight on daily manufacturing operations, development and approval of standard operating procedure, quality approval of deviations and final batch disposition. Responsibilities will include evaluation of compliance and quality issues, providing recommendations for improvement projects, and assuring progress of records to completion.

• Review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Electronic Master Batch Records etc.
• Provide quality oversight for quality records including deviations/CAPAs, technical change controls and work orders assuring adherence to procedural requirements and confirming assessments and evaluations of different partners are complete and accurate
• Driveinvestigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
• Ensure that all activities & related documentation for facilities, equipment, materials and processes align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Own quality related Standard Operating Procedures, Work Instructions, Forms and Methods and ensuredocument control excellence, including timely periodic review of controlled documents
• Provide quality oversight for manufacturing and be responsible for batch disposition.
• Provide quality and compliance expertise & guidance and agrees on strategies related to process lifecycle management.
• Support and represent Quality during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
• Support Lean Transformation and Operational Excellence initiatives

• Ensureproduction records and test resultsare accurate, complete, and inspection-ready
• Champion and leadcontinuous improvement initiativesto strengthen quality systems and operational performance
• Partner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible and driven individual with these qualifications

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 2 years of Quality and/or Manufacturing experience

Or

Bachelor’s degree and 4 years of Quality and/or Manufacturing experience

Or

Associate’s degree and 8 years of Quality and/or Manufacturing experience

Or

High school diploma / GED and 10 years of Quality and/or Manufacturing experience

Preferred Qualifications:

• Master's or Bachelor’s Degree in Science
• Educated in a science field with 5 years of experience in GMP/GCP operations or similarly regulated industry
• Affinity with digital innovation, data sciences and Quality engineering
• Experience in review/approval validation documentation
• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues
• Ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
• Experience working with dynamic cross-functional teams and abilities in decision making
• Strong organizational skills, including ability to follow assignments through to completion
• Strong leadership capabilities and experience applying GMP requirements in an operational setting
• Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.

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.

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.