QA Specialist - Digital QA/IS Validation
About The Position
Reporting to the Senior Manager Quality, the QA specialist for the Amgen Advanced Assembly and Final Product Operations facility will provide quality oversight support of the design, installation, commissioning & qualification of business software applications and automated systems. This can cover a wide range of quality processes that drive and govern operations in manufacturing, warehousing and quality assurance for the local site and the Amgen network. The QA specialist will also provide quality oversight for the manufacturing and warehouse digital operations. This role will require local presence at the New Albany facility near Columbus, Ohio. In this vital role you will be responsible for leading and guiding cross functional staff, under general supervision, as an informed Subject Matter Expert in the Digital Quality space related to computer systems validation and electronic records compliance. A key aspect of this role is to apply problem solving skills to ensure quality and compliance to ALCOA++ and GMP regulations for all area operations and associated processes. You will provide Quality oversight of the development and implementation of the digital advancement opportunities for the facility and will lead the digital Quality strategy for the facility.
Requirements
- Doctorate degree
- Master’s degree and 2 years of Quality and/or Manufacturing experience
- Bachelor’s degree and 4 years of Quality and/or Manufacturing experience
- Associate’s degree and 8 years of Quality and/or Manufacturing experience
- High school diploma / GED and 10 years of Quality and/or Manufacturing experience
Nice To Haves
- Master's or Bachelor’s Degree in Science, Computer Science, Engineering
- Educated in a science, computer science, engineering field with 5 years of experience in GMP operations, ICHs, 21 CFR Part 11, EU Annex 11 and similarly regulated industry
- Affinity with digital innovation, data sciences and Quality engineering
- Computer systems validation knowledge and experience with Automated Systems, Electronic Batch Record, Electronic Quality Management System, IIOT, Digital Control Tower, Advanced Analytics. etc.
- Proficiency with Microsoft Excel, Word, Power Point, Project, Access, and Visio; Adobe Acrobat; database related platforms; knowledge of Trackwise, PAS-X, Vault Quality Docs, SAP, LIMS etc.
- Experience in review/approval validation documentation
- Skilled in technical writing and critical reasoning
- Excellent written and verbal communication skills, ability to work in a team matrix environment and establish relationships with partners
- Great attention to detail and high degree of accuracy in task fulfillment and GMP documentation
- Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
- Experience working with dynamic cross-functional teams and demonstrate 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.
Responsibilities
- Provides quality and compliance expertise & guidance and agrees on implementation strategies related to the design, installation, commissioning & qualification, and process qualification of the digital manufacturing strategies for the facility.
- Identify digital advancement opportunities for quality and lead their implementation into the facility while ensuring Quality Processes are adhered to or adjusted as appropriate
- Collaborate cross functionally and across the Amgen Enterprise/Network to ensure digital advancement is implemented in accordance with established procedures and applicable regulations.
- Partner with other facilities in the network to ensure implementation of digital solutions and standard processes, consistency, and continuous improvement.
- Reviews and approves controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports.
- Ensures that all activities & related documentation comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Data Integrity, Safety, and Controls.
- Own quality related Standard Operating Procedures, Work Instructions, Forms.
- Ensure relevant processes, equipment, system are validated and the validation is current.
- 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
Benefits
- 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, including remote and hybrid work arrangements, where possible
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
