Quality Analyst

Ampcus, Inc
United States, Maryland, Gaithersburg
Jun 11, 2025
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: Quality Analyst Location(s): Gaithersburg, MD Accountabilities: Perform scanning, indexing, and electronic filing of executed GMP records in compliance with 21 CFR part 11 and internal SOPs. Ensure completeness, accuracy, and legibility of scanned documents prior to archiving. Support the retrieval and tracking of GMP records as needed. Identify and escalate documentation discrepancies or quality issues to QA Management. Collaborate with crossfunctional teams including but not limited to QC, Manufacturing, Facilities and Engineering, and Tech Ops, ensure timely processing of records. Utilize Veeva Vault or other electronic document management systems (EDMS) for uploading and indexing records, where applicable. Assist in the continuous improvement of documentation handling and scanning procedures. Maintain record retention logs and ensure adherence to established retention schedules (GRAD). Qualifications Bachelor Degree Prior GMP experience Experience with 21 CFR part 11 Experience Indexing, archiving, organizing, filing etc. 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.