Angel Vegas
Kansas City,MO
Summary
Seasoned Compliance Lead with a proven track record at Bayer Animal Health, excelling in regulatory compliance and critical thinking. Demonstrated expertise in quality assurance testing and fostering cross-functional team leadership. Achieved significant improvements in product quality and efficiency through meticulous root cause analysis and corrective actions.
Overview
20
20
years of professional experience
Work History
Compliance Lead / Product / Batch Record Release
Argenta Animal Health CRO/CDMO
Shawnee, KS
07.2005 - Current
- Primarily responsible for the review and release of batch records, relaying this information to the appropriate departments
- Storing of Batch records, cGMP documents, Lab modules.
- Weekly review and release of raw material and packaging component inspections
- Provide cross-training to support production activities.
- Conduct change management activities for batch record depository, solve any quality issues during and after manufacturing of the product.
- Provide support for the issuance of Batch Records for manufacturing execution, as required, utilizing SAP and Batch Record depository systems
- Auditing and supporting the development and improvement of quality systems, reviewing SOPs for revision updates.
- Highly proficient in the understanding, planning, training and supporting production needs to provide better results to QA.
- Self-motivated, with a strong sense of personal responsibility.
- Worked well in a team setting, providing support and guidance.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Organized and detail-oriented with a strong work ethic.
Issuance
Bayer Animal Health
11.2018 - 07.2020
- Developed and executed QA test cases, scripts and procedures for automated software maintenance.
- Fixed identified issues to improve workflows.
- Collaborated with QA analysts to establish, meet and maintain quality assurance thresholds based on best-practice tools.
- Designed, executed and maintained automated test scripts for in-project deployment.
- Documented testing procedures for developers and future testing use.
- Evaluated function, performance and design compliance of every product against design standards and customer needs.
- Incorporated delivery requirements into planning of testing schedules.
QCI Inspector
Bayer Animal Health
05.2013 - 11.2018
- Sampling of raw materials, both incoming and due for retesting, for submission to the Chemistry and Microbiological.
- Sampling and inspection of primary and secondary packaging components
- Data and entry into System of Inventory Record – SAP
- SPSC – Material / component receiving
- Maintained up-to-date inspection and audit records for improved reporting and analysis.
- Improved quality assurance procedures to minimize errors and increase effectiveness of inspections.
- Prepared reports detailing findings of inspections, investigations, and tests.
- Conducted detailed building structure inspections to identify and resolve potential risks.
- Led audit and inspection schedules for staff and contractors, meeting strict deadlines.
Weigh Area / Compounding Operator
Bayer Animal Health
09.2010 - 05.2013
- Maintained knowledge of industry policies and procedures to set up and operate equipment safely.
- Provided on-the-job training to newly hired workers and team members.
- responsible for transferring specific amounts of powder or liquid raw materials from the bulk container and into smaller units that will be dispensed in specific quantities for batch manufacture.
- Kept accurate records of defective units or products.
- Fed raw materials and components into semi-automated machines according to production needs.
- Maintained organized work area by cleaning and removing hazards.
- Met production targets and tight deadlines by collaborating closely with team members.
Non-Sterile Liquids Operator / Lead
Bayer Animal Health
09.2005 - 09.2010
- Responsible for various day-to-day functions, from set-up and loading to operating machinery with efficiency.
- Maintained clean, tidy and professional well operations in line with company standards (SOPs).
- Organized routine inspections to detect faults and arranged quick corrective actions.
- Trained new employees on proper protocols and SOPs.
- Reported issues to higher management with great detail.
Education
Associate Degree - Business
Penn Valley Community College
Kansas City, MOAssociate Degree - Industrial Relations
Carabobo University
Valencia, VenezuelaSkills
- Complex Problem-Solving
- Time Management
- Active Listening
- Critical Thinking
- Raw Materials/Components Specifications
- Documentation
- Regulatory Compliance
- Root Cause Analysis
- Quality Assurance (QA) Testing
- Corrective and Preventive Actions (CAPA)
- Cross-functional team leadership
- Customer needs assessment
- Product requirement documentation
- Product quality assurance
Affiliations
Experienced Quality Assurance / Batch Record Releaser with a demonstrated history of working in the pharmaceutical industry. Skilled in Microsoft Word, Sales, Continuous Improvement, U.S Food and Drug Administration (FDA), and Microsoft Excel.
Accomplishments
- Updated and resolved an obsolete SOP which led better understanding between the client and the company.
- Collaborated with team of 6 in the development of a new components library in order to perform better inspections for my inspectors.
- Achieved employee of the month by completing all the batches released with accuracy and efficiency.
Languages
4,5
Bowling
Bowling is a great way to relieve stress and unwind after a long day. The act of throwing a heavy ball down a lane can be therapeutic, and the social aspect of bowling can help take your mind off of whatever is stressing you out.
Languages
Spanish
Native/ Bilingual
Timeline
Issuance
Bayer Animal Health
11.2018 - 07.2020
QCI Inspector
Bayer Animal Health
05.2013 - 11.2018
Weigh Area / Compounding Operator
Bayer Animal Health
09.2010 - 05.2013
Non-Sterile Liquids Operator / Lead
Bayer Animal Health
09.2005 - 09.2010
Compliance Lead / Product / Batch Record Release
Argenta Animal Health CRO/CDMO
07.2005 - Current
Associate Degree - Business
Penn Valley Community College
Associate Degree - Industrial Relations
Carabobo University
Similar Profiles
Joshua JohnsonJoshua Johnson
Operations Manager at Launchworks CDMOOperations Manager at Launchworks CDMO
Azalia EsquivelAzalia Esquivel
Control Desk at Swiss American CDMOControl Desk at Swiss American CDMO
Amy HendrixAmy Hendrix
Receptionist at Societal CDMOReceptionist at Societal CDMO