Quality, Enviromental Monitoring, Change Control

Omar Romero

Oxnard, CA *****

(Email) *************@*****.***

Mainframe Security/Manufacturing/Quality Consultant

Objective

To obtain a challenging position within a company. With opportunity for growth and advancement, I pride myself in giving excellent service, loyalty, honesty, determination, and hard work. Ability to succeed in a team environment. Learn as much as I can to help and improve my work environment. To achieve upward mobility and to help and lead in my workplace.

Summary of Qualifications

Over ten years of manufacturing and quality department experience within GMP regulated environments.

Experience with hands on pharmaceutical manufacturing, quality document control/maintenance, change control, quality audits, and equipment calibration/maintenance.

Fifteen years of Department of Defense work.

Confirmed to be available for rotating shifts to include day and swing.

Education

High School Diploma June 1995; Rio Mesa High School/Oxnard, CA

A.A. Degree in Liberal Arts & Sciences, June 1998; Ventura College/Ventura, CA

B.S. Sociology; Crime and Corrections, California State University Northridge, December 2002

Volunteer Work & Awards

Volunteer:

Knights of Columbus- I am a 4th degree Sir Knight

Assist in helping feed, donate clothes to people.

Volunteer in cleaning and prepping the hall for special events.

Help and assist in charity functions.

The Clearwater Project- (Non Profit) 2000 - 2003; POC is Helen Meloy 805-***-****

Assist Federal and State convicts that are in a half-way house and are soon to be released on good behavior or time served in helping cope, adjust to be integrated in social life. I helped in being a part in groups that are intended in helping inmates build their social skills.

Individual Achievement Award 11/2007- Ten Year Award of Service for the Department of Defense (Navy), Pin and Award Certificate.

Professional Experience

SaniSure, Camarillo, CA

5/2018 to Present Quality Assurance Specialist

Position Summary: Collaborate with stakeholders to the management of the Quality System. Maintain, recommend and implements changes to the existing quality system with regards to nonconforming product, corrective/preventive actions, document control, quality control inspections and product release, internal audits, validations, Change Control Management, Environmental Monitoring, equipment calibration and maintenance programs.

Assemble meetings with stake holders, assign tasks for completion, contact vendors and customers for Change Control Management.

Responsible for the company’s Environmental Monitoring Program

Responsible for the Companies Calibrations and Maintenance Programs

Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements;

Conducts audits and reviews/analyzes data and documentation.

Responsible for the change control program

Initiate, investigate and complete nonconformance reports (NCR). Participate in the MRB meetings.

Responsible for facilitation of document control and training programs

Participate in the management of equipment, process and software validation.

Manage the equipment calibration and maintenance program. Maintain the inventory and status of measuring devices.

Provide help and support for all aspects of testing related to manufacturing.

oFirst article inspections

oIn-process release inspection.

oFinal QC release of finished goods.

oDocument review.

Ensures that all inspections and procedures are properly completed and documented.

Supports the environmental monitoring of cleanrooms and bioburden results. Provides solution for microbial failures.

Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process.

Participates on investigation of source materials for products and components.

Responsible for completing customer surveys and questionnaires.

California Pharmaceuticals LLC; Camarillo, CA

08/2016 to 4/2018 Manufacturing Associate/ Assistant Quality Control

Ensure and assist with site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections.

Essential Duties/Responsibilities:

Perform product inspection for defects, leaks and particulates.

Perform environmental monitoring of personnel (as needed) and complete documentation.

Assist in the media fill process validations to include inspection of filled units

Perform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets:

Verify that raw materials meet specification

Verify and account for labeling

Review temperature and alarms

Verify that product test results meet specification limits

Verify that all documentation is complete

Document non-compliance and work with supervisor/lead if further investigation is needed

Submit samples to the appropriate lab for particulate identification or microbial analysis.

Assist with equipment calibration program and maintenance record files.

Assist with raw material release and movement.

Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations.

Support internal & external audits.

Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).

Participate in Quality Manager’s staff meetings

Knowledge of pharmacy operations and regulatory guidelines.

Ability to perform calculations.

Ability to work within established procedures and practices

Strong organizational skills and attention to detail

Ability to effectively troubleshoot issues.

Baxter/ Baxalta; Thousand Oaks, CA

05/2013 to 05/2016 Manufacturing Associate I

As a Manufacturing Associate I am responsible for the following:

Prepare media and buffer solutions.

Operate Clean-in-Place (CIP) and Steam-in-Place systems.

Assemble and operate filtration systems

Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.

Monitor and record critical process parameters

Complete all relevant paperwork following GDP/GMP guidelines.

Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion.

Perform sampling using aseptic techniques

Participate on Continuous Improvement Teams

Receive and distribute supplies into production areas as necessary.

Train and mentor other team members

Revise and review pertinent documentation as appropriate

Assist in troubleshooting process problems and responding to alarms

Baxter Bioscience; Thousand Oaks, CA

Manufacturing Technician I

Under the immediate direction of the Formulation/Finishing Lead and overall directives of the supervisor, this position is responsible for the bio decontamination and appearance of the Bulk Formulation, Preparations, Aseptic Filling, and Sterility test room. Responsibilities also include the stocking of supplies, flushing of WFI lines, maintaining individual training records, and proper handling and removal of hazardous waste. As well as assisting in the training of new employees.

Manufacturing Technician II

The Manufacturing Technician II is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. Fully participated in both departmental projects and any quality working teams which may be applicable. Under the general direction of the lead technician and the overall direction of the supervisor, I was responsible for the hands on execution of all activities in the production area.

• Supports all local manufacturing operations.

• Performs cryo suspension, filter clarification, chemical additions, dilutions, sterile filtration and other activities related to the manufacture/processing of AHF-M bulk.

• Operate general production equipment (such as Westfalia centrifuge, autoclave, Clean In Place /Steam Rinse, MAb/Q-Seph Column Chromatography, Nanofiltration Skid, etc.)

• Complete relevant paperwork following GDP/GMP guidelines.

• Manually clean all portable equipment and small parts.

• Participate on Safety and Continuous Improvement Teams.

• Receive and distribute supplies into the production area as necessary.

• Perform daily cleaning of the production area to maintain GMP compliance.

• Prepare media and buffer solutions.

• Perform disposal of hazardous waste

• Assemble and operate filtration systems.

• Participate in the revision and review of pertinent documentation as appropriate.

• Train new employees on procedures for which MT II is qualified as trainer.

Navfac Information Technology Center (NITC); Dept. of the Navy / Port Hueneme, CA

2004 to 2012 Mainframe Security Administrator

- Tasked as the Mainframe Security Administrator Project Manager for the NITC Enterprise Operations Branch, Code IT32, GS 9-11. As Mainframe Security Administrator, I have working knowledge of IBM’s Resource Access Control Facility (RACF) system. I work independently and with minimal instruction from supervisors, project managers, and support staff on security tasks as follows. Based on the SAAR forms submitted to me; I administer user profiles, accounts, privileges and access rights for the NAVFAC mainframe application systems maintained by NITC and hosted at the Defense Information Systems Agency (DISA) Ogden, Utah Operation Center as well as NAVFAC web based enterprise applications hosted at NITC.

- My account administration duties encompass security coordination with NITC project managers, system administrators and NAVFAC field Terminal Area Security Officers (TASO) to establish user accounts with sufficient privileges to allow access to mainframe applications and/or locally hosted enterprise applications. Working with the TASO’s, from the SAAR forms submitted to me. I make sure that the customer has sufficient access to do their job. I coordinate with DISA and NAVFAC TASO’s to maintain accurate and appropriate mainframe application and system access rights and to remove inactive accounts to prevent unauthorized system intrusion. I work directly with users to reinstate user access to the mainframe environment, I create user list reports assisting in report distribution set up with CA-Webview.

- I act as a liaison between users and DISA to convert accounts from Secure Web Access (SWA) to the mainframe Multi-Host Internet Access Portal (MIAP) access application. I work closely with DISA to mitigate resolution of mainframe STIG security violations, including securing account groups and sensitive datasets to exclusive primary users. I assist with storage optimization of the mainframe. This area deals with cost cutting moves like moving information from tape to virtual disk, reducing space by eliminating unused Data Queries, Job Schedules, JCL, and obsolete datasets. I also assist in mainframe database support on the CASEMIS, SUPMIS, CESMIS, FIS applications, and the ieFACMAN Integrated Data Store. I develop, test, implement, and maintain JCL, jobs, and schedules used in mainframe application batch processes, trouble-shoot errors and process failures as they occur. I work closely with the CDA’s and application developers in resolving JCL problems. I was the co-project lead on the FY 11, FY 10, FY 09, FY08 FIS EOY/BOY projects.

- Experience in disaster recovery, I was involved and lead teams in testing for recovery of data in case of a disaster. As part of a disaster team, I helped implement primary backups and successfully mimicked the results in our secondary storage. I developed systems procedures for department users and maintained systems documentation.

Navfac Information Technology Center (NITC); Dept. of the Navy / Port Hueneme, CA

2004 to 2008 Information Assurance (IA)

- I worked in the NITC Information Assurance (IA) Branch, Code IT31 GS 7- 9; where I gained expert knowledge of user account administration in Citrix and Oracle Collaborative Suite (OCS). I also was responsible for Web Site Accreditation. I was the mainframe account administrator for CICS, Dataquery, ROSCOE and TSO via Vanguard Administrator running on IBM Security Server using the user account administration tool Resource Access Control Facility (RACF).

-I created and maintained historical account access records for audit purposes. I assisted inventory management of all hardware going in and out of NITC using DAPS (Defense Property Accountability System). In inventory management I processed materials and data in and out of the building. For inventory record purpose I documented all lost, obsolete, marked for waste, and or donation.

Navfac Information Technology Center (NITC); Dept. of the Navy / Port Hueneme, CA

1997-2004 Help Desk Operator

- As a NITC Help Desk operator GS 5 – 7 for a call center, I ordered office supplies, filing, and faxed. I provided customer service in the following areas; I answered trouble calls, opened trouble tickets and performed first level triage of user problems related to mainframe access, computer hardware, or network access problems.

- I was responsible for monitoring mainframe production system applications using the Control-M application to insure updates were run successfully and on time. I was responsible for determining the nature of the mainframe batch process failures and to contact the program support staff to expedite correction of the problem. I assisted users with mainframe login problems and dequed runaway or locked tasks and programs. As well as attending weekly safety training meetings.

Additional skills

I hold professional licenses/certificate training in these areas.

Rockhurst University Continuing Education Center; Advanced Excel for Power User, fall 2003, 2008.

Defense Property Accountability System Inventory Management DPAS Certificate, 06/02/03.

Enterprise Security Solutions & RACF Users Training, Spring 2006, 2008, and 2009.

Techknowledge Training- JCL Workshop, fall 2008.

CompTIA Security Plus, Fall 2008.

California Sales License 2013,

Working knowledge of Microsoft Office, Word, Excel, Power Point.

Yellow Belt in Lean Manufacturing Process; Baxter 2014

ISO 9001:2015 Internal Auditor (TPECS) Certificate 11/2022

ISO 19011:2018 Auditing Module Certificate 11/2022

ISO 17025 Laboratory QS Internal Auditor

Hub Spot: Help Desk Ticket System

Security Clearence (Interim)

I speak, read and write English & Spanish.

References

Name Employer Title Phone Email

Irma Gonzalez NITC IT 31 Project Manager; 805-***-**** ****.********.***@*****.***

Douglas J. Barron Defense Info Systems Agency; Consultant; 805-***-**** *******.*.*******.***@****.***

Afzal H. Khan NITC IT Project Management; 818-***-**** *****.****@****.***

Claudia Gomez SaniSure Quality Specialist 323-***-****

Vanessa Ortiz Community Memorial Hospital; City of Ventura LVN/Pharmacy; 805-***-**** ***************@*****.***

Cindy Clavel SaniSure Global Quality Manager 805-***-**** ***********@*****.*** Indicates professional reference

R,

Omar Romero

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