Devin Cosom Email & Phone Number

Glen Burnie, MD, US

Taipei, Taiwan, TW

Emergent Camden facility was acquired by Bora Pharmaceuticals August 2024.

Gaithersburg, Maryland, US

• Supplier Quality Management (SQM)o Partner with Supply Chain and Global Supplier Quality teams to execute required activities for the qualification and monitoring of suppliers.o Evaluate new supplier requests and.
• Material Managemento Perform/support performance of elemental impurity and EU risk assessments, upon request.o Manage the assessment and implementation of supplier-initiated change notices (SICNs) related to local.
• External Supplier Auditso Communicate with Global Supplier Quality team to monitor schedule and execution of audits of suppliers supporting the Camden and MDCW facilities.
• Owns, approves, and participates in CAPAs, deviations, and change controls related to the above functions
• Revises Standard Operating Procedures and forms, as needed.
• Support other activities within the QA department, which may include providing compliance metrics for site and corporate management, supporting regulatory inspections, client audits, annual product reports and other.

Somerset, NJ, US

• Responsible for and administers Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution
• Responsible for and administers the CAPA Tracking System for general GMP use and internal audits. Track the timely completion and extension of commitments
• Perform trending review of deviations and investigations, compile report and identify trends or areas requiring additional actions
• Responsible for and administers the change control system for tracking and coordinating the initiation, execution and completion of change controls
• Responsible for and administers the Risk management system and track completion of risk assessments
• Compile pertinent QA metrics for Senior Management review

Gaithersburg, Maryland, US

Participates in oversight of Internal Audit and Supplier Quality Programs with guidance from managementLeads internal and external audits of the various quality elements to ensure compliance to regulatory commitments and requirements, industry best practices and guidancesEvaluates and presents solutions on complex issues (i.e. major deviations) with.

Brentford, Middlesex, GB

• Maintain monthly site KPI metrics for above-site reporting
• Write and review cGMP Standard Operating Procedures and Work Instructions
• Develop and facilitate Data Integrity and Inspection Readiness Trainings
• Manage third-party and regulatory inspections including management of CAPAs
• Manage and facilitate site Inspection Readiness Program
• Manage semiweekly area GEMBAs for inspection readiness

Brentford, Middlesex, GB

Streamlined and manage the Raw Materials Reduced Testing Qualification and Verification process, including data integrity review.Manage part number approval process for GMP materials including initiating desktop audits.Assess and implement supplier-initiated change notifications through the change control system within M-ERP.Manage the data collection.

Brentford, Middlesex, GB

• Manage GMP Standard Operating Procedures, Work Instructions, Forms, Batch Records, Product Specification and Stability Data Table workflows within QUMAS document repository system.
• Perform self-inspection and internal audit inspections.
• Provide audit support for corporate, regulatory, and third party audits.
• Facilitate logbook documentation training for new hires and refreshers.
• Assist with implementation and monitoring metrics for site self-inspection program.
• Analyze department training metrics.

Brentford, Middlesex, GB

• (GSK acquired Human Genome Sciences in 2012)
• Completed compedial testing for Appearance, pH, Osmolality, Coulometric Residual Moisture, and Subvisible Particulate Matter for cGMP products.
• Successfully implemented the Retain Storage Location Management system in LIMS, including manual labeling of 10,000+ samples.
• Generated Certificates of Analysis for drug substance products manufactured in multiple cGMP value streams.
• Managed Reference Standard inventory for current and historical bulk drug substance products.
• Managed QC production sample scheduling to promote prompt product testing.

• Retrieved and analyzed Compliance reports daily for suspicious activity and suspected money laundering.
• Prepared and electronically filed CTRs and SARs for the Bank.
• Compiled and distributed committee packages monthly.
• Assisted in drafting monthly Board Reports and Internal Regulatory Compliance Committee Reports and minutes.
• Assisted and conducted internal audits to ensure compliance with BSA and AML regulations.
• Assisted with the development and implementation of the bank's first AML computerized database.

• Processed international and domestic wires.
• Processed branch insufficient funds decisions daily.
• Completed research requests from branches on all deposit accounts.
• Processed levies, garnishments, and attachments for deposit accounts.
• Enrolled business and consumer customers in our on-line banking system.
• Balanced branch totals daily prior to sending transaction files to FISERV.

• Oversee branch compliance with established policies, procedures, timely audit requirements, and efficient resolution to operational issues.
• Hold responsibility for operational/procedural training of branch staff and convey information and updates in a timely manner.
• Resolve customer relation issues through courtesy, respect, and effective negotiation.
• Balance branch daily, including identification and correction of teller differences.
• Assist in answering telephones, and performing teller duties as needed.
• Order and ship cash weekly to the Federal Reserve Bank.

Jersey City, NJ, US

• Provident Bank was acquired by M&T Bank in 2009.
• Settle cash drawer, ATM and vault daily with accuracy.
• File Monetary Instrument Reports, Currency Transaction Reports, and Suspicious Activity Reports.
• Ordering and shipping cash to the Federal Reserve Bank.
• Balance branch daily, including reconciling teller differences.

Bachelor'S Degree, Health/Health Care Administration/Management

Associate'S Degree, General Studies

Master Of Science - Ms, Biotech - Regulatory Affairs