Experienced, skilled and detail-oriented quality assurance and document control specialist with strong background in quality assurance/document control and processing systems. A solid record of success and reliable in completing accurate work over 19 years of progressive training and experience. Careful to check and verify documentation to prevent errors and minimize rework. Desire to bring abilities gained to pursue dynamic, growth-oriented position focused on continuous improvement and optimal workflows.
Work History
Senior Document Control Associate
Nutramax Laboratories, Inc.
Edgewood, MD
2007 - 09.2023
Promoted to Senior Document Control Associate. Also responsible as Quality Assurance Technician for a couple of years.
Report to Quality Assurance Manager.
Responsible for processing and maintaining the documentation systems, such as Standard Operating Procedures, Raw Materials/Finished Products/In-Process Specifications, Batch Records, Analytical Chemistry/Quality Control/Quality Control Microbiology Test Methods, Change Controls, Request for Destruction, Document Requests, Customer Complaints, Adverse Event Reports, AHPAERs, Logbooks/Notebooks, Office Archives, Deviations and Investigations.
Ensure the proper workings of all document control systems in order to meet our internal customer's needs.
Ensure that the processing takes place in a timely manner.
Ensure that the work is complete, accurate, and organized accordingly in order to facilitate the needs of manufacturing operations by working with supervisor, manufacturing, packaging, planning, etc.
Ensure that the cGMPs and company SOPs are adhered to at all times.
Assigns report numbers, verifies, issues and processes documentations. Issue and check batch records for production in a timely manner.
Writing and revising the SOPs to match current practices.
Identify the correct document and communicate with outside vendors to ensure timely retrieval, archiving and processing of each document.
Accurately inventory documents and logbooks while keeping information in spreadsheet up to date and accurate.
Work together with another departments to meet company goals. Provide assistance to another departments to resolve the issues related to Document Control Systems.
Train another Document Control member.
cGMP and Batch Record Reviewer Trainings.
Performing other duties required for meeting company goals at the direction of Supervision.
Quality Assurance Technician
Nutramax Laboratories, Inc.
Edgewood, MD
2006 - 2009
Promoted to Quality Assurance Technician.
Responsible for Incoming Process, Document Control Process and In-Process Inspection.
Receive and release printed materials and packaging components.
Update all appropriate logbooks and maintain work areas.
Reviewing and processing all appropriate documents, including the change control system.
Responsible for performing finished product inspection and line clearance for the Manufacturing and Packaging.
Conduct periodic internal inspections to ensure Manufacturing and Packaging personnel are following the safety rules, as per cGMPs and company SOPs.
Responsible for delegating work to one or more Incoming/Label Issuance Associates.
Performing other duties required for meeting company goals at the direction of Supervision.