Mark Anthony Hernandez Email & Phone Number

Mahwah, New Jersey, United States

New York, New York, United States

Greater New York City Area

Greater New York City Area

Database modeling for transfer pricing solutions as part of the Intercompany Design and Execution team. (formerly known as E2E, End to End Transfer Pricing).

Pine Brook, Nj

• Management of Regulatory information throughout the product lifecycle with the creation of regulatory database.• Published eCTD submissions using applications including Lorenz software and TRS/ISI ToolBox with dispatch through ESG.• Preparation and review on more than half a dozen ANDA submissions.• Established of documentation templates and publishing standards• Decreased publishing time by two thirds with the procurement, implementation, and training of new technology.

Woodcliff Lake, Nj

• Prepared amendments and supplements to FDA with interaction with other departments to coordinate eCTD submissions• Provided regulatory assessment for CMC changes• Experience with Sterile products• Led global cross-functional teams to generate multiple complex regulatory filings against aggressive deadlines• Trained 6 temporary workers simultaneously to full-time associates and trained management to changing company procedures.• Fostered collaborative environment with multiple departments for policy implementation and process harmonization.• Established submission standards, templates, and protocols with improved regulatory compliance and technological efficiency (use of Mail merge/Access databases) in order to adapt to organizational changes.

Pittsburg, Ca

• Streamlined information flow and decreased inefficiencies by enhancing existing ERP system through scripts and programs (mostly in VBA) for Quality, Accounting, Purchasing, and Operations departments.• Represented company in FDA, customer, agency audits• Developed and implemented new systems and redeveloped existing ones:• Master Validation Plan, Facilities and Equipment systems, Change Control System, Training Program, Documentation practices, Material Nonconformance, Deviation/CAPA, OOSValidation work included:• Process, Equipment Qualification (IQOQPQ), Cleaning, Electronic Spreadsheet.• Developed, reviewed, and approved production records, forms, SOPs, batch records, work instructions, specifications.Other duties included:• Deviation/complaint investigation, audit responses, production scheduling, technical support.Assisted in:• Method development, stability chamber repair, costing, pricing, financial modeling.

Bs, Biomedical Engineering (Biochemical Engineering)

Activities and Societies: Troy Philippines, Daily Trojan, CFC Youth

Education record

Certification, Lean Six Sigma Black Belt