Qualification Specialist

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: Qualification Specialist

Execution of qualification activities (IQ/OQ/PQ) for manufacturing equipment, processes, and materials within Enterprise Quality - Change Management & Systems. Supports the Change Control & Qualification team's protocol execution, documentation, traceability, and record management workload. Day-to-day direction from Manager.

• Hands-on execution role supporting equipment and process qualification activities within a manufacturing environment.
• Draft, execute, and close out Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for manufacturing equipment and systems.
• Generate qualification reports, document results, and ensure full traceability of records in accordance with internal procedures and applicable regulatory requirements.
• Coordinate closely on the factory floor with Manufacturing, Engineering, Quality, and Project teams to complete qualification testing around production windows.
• Support documentation remediation, record management, and change-control linkage for qualified equipment.
• Success is measured by timely, right-first-time completion of qualification deliverables.

• Bachelor's degree in a technical discipline (equivalent hands-on qualification experience considered in lieu of degree).
• 5 years executing equipment qualification (IQ/OQ/PQ) and process validation in a GMP or otherwise regulated manufacturing environment.
• Demonstrated experience authoring and executing protocols and writing summary reports, including deviation/discrepancy documentation and traceability.
• Working proficiency with electronic quality systems (e.g., TrackWise or comparable eQMS), document management systems, and MS Office/Excel; validation or quality certification (CQE, CQA, ASQ, or similar) preferred.

• Health & Wellness: Comprehensive pre-tax health, dental, and vision insurance options.
• Life Insurance: Group term life insurance and voluntary life insurance coverage.
• Retirement Savings: 401(k) retirement savings plan to help you plan for your future.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.