Overview
Quality Analyst Jobs in Gaithersburg, Maryland, USA at Ampcus Inc
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 cross functional 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
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.
About the company
Ampcus Inc. is an ISO 20000, ISO 27000, ISO 9001, CMMI DEV/3 SM, and CMMI SVC/3 SM certified global provider of a broad range of Technology and Business consulting services. From strategy to execution, our disciplined yet flexible approach starts and ends with our clients. By listening hard and working harder, client goals become our goals.
Notice
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Title: Quality Analyst
Company: Ampcus Inc
Location: Gaithersburg, Maryland, USA
Category: Quality Assurance – QA/QC (Data Analyst)
