Career CategoryQuality
Job DescriptionSpecialist QA
What you will doLet'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
- Drive investigations 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 ensure document 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
- Ensure production records and test results are accurate, complete, and inspection-ready
- Champion and lead continuous improvement initiatives to strengthen quality systems and operational performance
- Partner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders
What we expect of youWe 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 usAs 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.
Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.
careers.amgen.comSalary Range104,287.35USD -141,094.65 USD
