David Perez

Illinois ***** 1-847-***-**** adyfhf@r.postjobfree.com

http://www.linkedin.com/pub/david-perez/12/499/790

Cybersecurity professional with over 10 years of experience in an administrative environment in Quality/Regulatory Affairs in the Medical, Devices/Pharmaceutical industry. Transitioning into Information Technology/Cybersecurity with experience/education in:

Auditing,, ISO regulations (13485, 9001, 27001, 27002, 27032, etc.) Risk Analysis, various technology platforms/software, FDA regulations (e.g. 21 CFR 820), National Institute of Standards and Technology Cybersecurity Framework (NIST CSF).

Enthusiastic approach to work, strong analytical skills with critically thinking aspect to solve complex problems accurately in a fast paced environment in respect to deadline oriented tasks, strong verbal and written communication skills to convey complex ideas succinctly within a team environment.

Certificates in Python, Mean, and C#

Multilingual; English, Spanish, etc.

EDUCATION

Purdue University Global

Bachelor of Science, Cybersecurity May 2022

Coding Dojo Chicago, IL January 2020

Full Stack Web Development Certificates in Python, Mean, C#

Northeastern Illinois University, Chicago, IL December 2007

Bachelor of Arts, Life Sciences

EC Council courses

Hack a Drone program

Network Defender

AWS Cloud Practitioner Essentials training

Cloud and cloud integration courses

TECHNICAL SKILLS

• Computer proficient in multiple programs: Adobe Acrobat, APLM (Abbott Product Lifecycle Management), Edocs system, FlexQ,

Flex Medical, Linux, Lotus Notes, Microsoft Office programs (e.g. Access, Excel, Outlook, PowerPoint, Word, Visio, etc.), Quark

Express, SAP (PLM), Salesforce, SharePoint, SPSS, and Trackwise.

A versatile knowledge of e-mail formats and web based storage programs, Internal Abbott, Baxter, and Hospira portals, excellent

internet research skills, ISO 13485: 2016, ISO 9001, etc.

• Additional Experience: AWS Cloud Foundations Learning Plan, HackTheBox (Nmap, port scanning, etc.), TryHackMe

(Burp Suite, OWASP, etc.), cloud based storage solutions, Virtual Machines, Wireshark, etc.

PROFESSIONAL EXPERIENCE.

Contract Employee 2012-present

Various administrative roles across multiple organizations including:

Cybersecurity Analyst Purdue University Global Indiana (internship remote) 03/2022-05/2022

• Documented security breaches and assessed potentially compromised systems.

• Monitored computer networks for security issues, presented initial risk analysis of potential security issues.

• Fixed detected vulnerabilities to maintain a high-security standard.

• Presented current Information Technology (IT) security trends/news to the team e.g. being up-to-date on changing threat landscape,

privacy rules and regulations, security best practices, and communicate findings to the team /best practices maintained/supported

information security policies, processes, and procedures.

Quality Specialist Alma Lasers, Buffalo Grove, IL 11/2020-04/2022

• Ensured current and accurate quality system documentation, coordinated and/or performed testing of quality system modifications.

Provided quality systems expertise and supported various system trainings, educational tools, materials, etc.

• Point of source for quality/regulatory questions and influenced users regarding current and potential inputs, processes, outputs.

Researched and analyzed the effect and results of quality/regulatory problems.

• Collaborated with applicable functional areas (SMEs, CFTs, etc) to develop an improved understanding of the varied and complex

business needs supported by the system.

• Performed quality audits for compliance with applicable quality corporate and divisional (departmental) policies and procedures.

• Produced and presented reports, time lines, and graphics using advanced functions of various software utilizing the necessary devices.

Created reports from existing (and nonexistent) databases to satisfy FDA, ISO, and corporate requirements, provided metrics to show

upward and downward trending (e.g. project analysis).

• Applied various solutions to incorporate technology, business, and/or appropriate departmental areas of concern to formulate the

applicable solution (e.g. IT, business, etc.) to resolve or improve a myriad of business problems.

• Led CAPA investigations from onset to closure, presented progress and hurdles on a bimonthly basis to executives and related

company heads.

• Coordinated external auditors; prepared controls owners, reviewed, and collected required evidence (records, etc.) as needed to meet

requirements.

• Supported various departments with establishing new procedures/policies and ensured alignment/compliance with regulations/standards.

• Performed Risk Analysis on various projects, proposals, for various business and quality/regulatory needs and requirements.

David Perez adyfhf@r.postjobfree.com

Supplier Quality Technician SC Johnson, Sturtevant, WI 06/2020-11/2020

• Collaborated to ensure quality of products manufactured at Third Party Suppliers (TPMs) throughout their development.

• Provided metrics (pivot charts, pareto charts, etc.) using Excel, Minitab, Access, and SAP PLM for various meetings, managers,

performance monitoring (defects, rejects, etc.) of Third Party Manufacturers (TPMs), vendors, and suppliers.

• Responsible for placing products on hold and affirmation of the release after holds have been resolved.

Technical Writer Protocol Link (Pharma), Vernon Hills, IL 07/2019–09/2019

• Drafted Standard Operating Procedures (SOPs) for a Pharma nutritional Manufacturer.

• Drafted GMP Quality System and Work Process Flow procedures (CAPA process, quality procedures, etc.).

• Communicate with Manufacturing, Quality, and MS&T personnel while managing multiple priorities simultaneously.

• Managed continuous compliance with the policies and requirements of Protocol Link, the client, industry norms, and cGMP regulations.

• Managed client expectations efficiently with minimal guidance. Maintain strong working relationships with all client representatives.

PSCP Editor (Change Control) Abbott, Lake Forest, IL 03/2018-04/2019

Creating and routing of new change control documentation as well as modifying / editing existing documentation, documents that include but are not limited to Material Specifications, Purchased Standard Control Procedures (PSCPs), DCRs, PCNs, etc.

Gatekept for ad hoc content requests, ensuring team utilization is balanced. Contributed to leveraging content to enhance internal organizational alignment and employee engagement. Synergistically applying a holistic view across enterprise wide communications messaging and in producing appropriate, timely and related content.

Creating and organizing an internal quality system for version control (various documentation improvements), training employees, implementing process improvements.

Works synergistically with global Subject Matter Experts (SMEs), Cross Functional Teams (CFTs), and Technical Product Developers (TPDs) to ensure product specifications meet requirements.

QA Analyst / Document Control Compliance Flex (Medical Devices), Buffalo Grove, IL 05/2017-03/2018

• Provided metrics for the management review on a monthly basis using Excel, Minitab, and PowerPoint. Metrics were used to evaluate

performance monitoring and to improve supplier monitoring relations.

• Auditing, interpreting, and implementing new quality requirements in a start-up site (e.g. compliance with ISO standards,

Federal regulations (result of an FDA visit), Customer requirements, etc.).

• (CAPA Coordinator role) updating CAPAs, nonconformances, etc. metrics to present to the General Manager during weekly

meetings, preparing monthly metrics for management review, CAPAs, nonconformance, etc training and meeting to progress closure.

• Special projects as assigned by Compliance Manager and/or director (Assisting in CAPAs (NCMRs), ISO 13485: 2016 updates,

audit responses, etc.).

• Strategized with Quality Engineering to go over new regulations, customer requirements (Abbott, etc.), corporate policies and how

best to implement processes improvements.

• Coordinated CAPA investigations from onset to closure, presented progress and hurdles on a weekly basis to executives and

related company heads.

Document Control Manager Supplier Quality Hospira, Lake Forest, IL 09/2016-12/2016

• Approving, reviewing, and submitting Supplier Quality (reports) of Hospira documents for the remediation process of Third Party

Manufacturers (TPMs).

• Researched and datamined specified documents from client databases and archives to support execution of gap assessments.

• Prepared, reviewed, and presented electronic documentation for gap assessments.

• Created evaluated, and structured data for an internal database (SharePoint).

• Lead CAPA investigations from inset to closure, presented progress and hurdles on a bimonthly basis to executive teams and related

company heads.

Change Control Abbott, Lake Forest, IL 09/2015-01/2016

• Process change requests (SOPs, records, forms, etc.) this includes doing an impact assessment, Change, Reason, and Justification (CRJ)

check on the requested changes, checking implementation date, creating a differences document, and verifying what type of

document it is for implementation (training impact).

• Met various FDA deadlines to implement updated revised documents

• Performed a search to identify potentially related documents on the requested change.

• Communicated with various Subject Matter Experts (SMEs), Cross Functional Teams (CFTs) and technical experts in updating

procedures.

• Troubleshot and resolved any issues related to the APLM system.

Document Control Manager / Supplier Quality Control Medtorque, Chicago, IL 01/2015-09/2015

• Process change requests (includes creating SOPs, Work Instructions, etc.) This includes doing a Change, Reason, and Justification

check on the requested changes, checking implementation date, creating a differences document, and verifying what type of

document it is for implementation.

• Training: Implemented new Quality System and updates to the system to the entire plant, various Quality Systems (GDP, GMP, ISO and

compliance with class 3 device federal regulations.

• Reviewing issued nonconformances, CAPAs, etc. Met with QA manager, director, etc. and investigated nonconformances,

CAPAs, etc. addressed issues and updated training and procedures based on the result of investigations.

• Created database from scratch to store various records, validations, procedures, etc.

• Assisting in re-certification of various certifications, required validations, etc. (ISO 13485, 9002, etc.) Managed multiple projects in

preparing for re-certifications, validations, etc.

David Perez adyfhf@r.postjobfree.com

Regulatory Affairs/Document Control Hospira, Lake Forest, IL 03/2013-12/2014

• Approving, reviewing, and submitting Regulatory Gap Assessments (reports) of Hospira products for the remediation process based on

Good Manufacturing Practices (GMP).

• Consultation, feedback, and training of Quality Assurance department on creation of documents.

• Comprehend regulatory standards/ documents; identify compliance risks and resolve or escalate when necessary.

• Gather specified documents from client databases and archives to support execution of gap assessments.

• Organize completed technical gap assessment procedures that require evaluation of documents and comparison of test methods

to source documents.

• Prepare electronic documentation of gap assessments and product summary packets for filing either electronically, scanning

and or in paper format within client document control systems.

• Data mined Common Technical Documents (CTDs), organize for an internal database (SharePoint) and maintain that structure.

Medical Device Reporting Hospira, Lake Forest, IL 11/2013-05/2014

• Approved, reviewed, and submitted Medical Device reports in compliance with Hospira and FDA guidelines.

• Perform quality review of medical device reports.

• Worked closely with senior management to elevate and streamline the accuracy of device reporting to the objected goal of 80 percent.

• Utilized TrackWise to update and input medical device complaints.

• Familiar with complaint reporting regulations governing for EMEA, APAC, Canada, and the Americas.

• Prepared metrics, participated in initiates for problem resolutions, utilized technology to expedite solutions.

Customer Information Analyst Grainger, Niles, IL 08/2012-03/2013

• Prepares source data for computer entry by compiling and sorting information; establishing entry priorities.

• Processes customer and account source documents by reviewing data for deficiencies; resolving discrepancies by using standard

procedures or returning incomplete documents to the team leader for resolution.

• Verifies entered customer and account data by reviewing, correcting, deleting, or reentering data; combining data from

both systems when account information is incomplete; purging files to eliminate duplication of data.

• Secures information by completing data base backups.

• Maintains operations by following policies and procedures; reporting needed changes.

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