Edwin Joel Soto Ortiz

**** ******** **** *** # *** San Antonio, TX 78218

787-***-****

ac35me@r.postjobfree.com

Biologist

Biologist with over seven years of experience in Quality Assurance for Pharmaceutical, Biotechnology, Medical Devices and Aerospace and Defence Industries. Strong knowledge in Quality Assurance troubleshooting and technical support. Goal oriented with setting and maintaining quality standards aligned with current GMP's, FDA, TUV, ISO and OSHA rules. Experienced in Warning Letter and Consent Degree Status.

Skills

Fully bilingual and strong oral and written skills. (Able to read, write and speak English and Spanish). Strong knowledge in statistical data analysis and problem solving techniques. Microsoft Office proficiency (Word, Excel and Power Point)

Work Experience

QA Auditor Associate

June 2017 to Present.

(Temporary relocation to Accenture 6415 Babcock Rd #100, San Antonio, TX 78249, 210-***-****)

Performs quality assurance of First Article Inspection to aerospace and defense standard documents, drawings and work instructions.

Performs peer checks of FAI’s.

Ensures all documentation is completed correctly.

Ensure all necessary paperwork and processes are completed following a discrepancy incident to allow build to continue.

AS9102

ASQR-01

Computer applications:

SAP

QCPC

FAI Tracker

Via Search

EIS

IHS

Assist

Performs final approval of FAI’s

Sr. Associate QA for Incoming and Supply Chain (Spectraforce Technologies, Inc.)

November 2015 To May 2017 Amgen Manufacturing Limited, Carr 31 km 24.4, Juncos, PR. 00777 787-***-****

Responsible for providing Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.

Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.

Responsible for Quality disposition (approval or rejection) of raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas.

Supports Continual Improvement initiatives, programs and projects

Ensures that changes that could potentially impact product quality are assessed according to procedures

Ensures that deviations from established procedures are investigated and documented per procedures

Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements

Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures

Alerts senior management of quality, compliance, supply chain and safety risks

Supports internal/external audits and inspections as part of the audit/inspection management team as needed

Completes required assigned training to permit execution of required tasks

Performs additional duties as specified by management

Provide guidance on quality systems and compliance with applicable regulations

Collaborate with cross-functional teams

Develop, implement and assess solutions for complex problems

Source Inspection Technical Specialists (Part-time/ Contractor)

September 2015 to December 2015 NTS Unitek Technical Services 5900 Fort Drive, Suite 100

Centreville, VA 20121 703-***-****

Perform inspections and assist suppliers in identifying and preventing nonconforming/noncompliance product to improved quality, increased reliability, and significant cost reduction

Practical experience performing in-process and final inspections on machined parts, assemblies, and / or sub-assemblies.

Engineering requirements specified per ANSI Y14.5 – Geometric Dimensioning and Tolerance (GD&T) or equivalent standard.

Ability to read / interpret engineering drawings and Purchase Orders (POs).

Experience using various mechanical inspection tools, such as micrometers, calipers, pin gages and micro view systems.

Experience performing First Article Inspections (FAIs) according to AS9102 and ISO9100

Screw Machine Quality Control

July 2014 to July 2015 Positronic Industries Caribe Inc., Ponce, P.R. 00728; 787-***-****

Complete understanding of geometric dimensioning and tolerance measurements. Duties include but not limited to First Article Inspection, in-process and final inspection of complex precision machined parts. Performs complete layout inspection by measuring dimensions, such as length, height, deep and distance between reference points, using precision instruments such as micrometers, calipers, pin gages and Micro View Systems to ensure product meets specifications. Able to locate reference point(s) on part and measure dimension such as angle, arc, and radius and diameters. Visually compares work pieces against one another to assess/detect manufacturing variations in processes. Reports quality problems or findings to Quality Control Manager and follows up to ensure that corrective action has/will take place. ISO 9001, ISO 9002 and AS9102

Quality Assurance Specialist

Nov 2006 to April 2008 Wyeth Pharmaceuticals, Carr 3 Km 142.1

Guayama, P.R. 00784, 787-***-****

Provided Quality Assurance support to Manufacturing and Testing Operations relative to the production of commercial and clinical products in a Warning Letter Consent Degree.

Complied with guidelines related to setting up and maintaining quality standards aligned with US FDA, current GMP's and SOP's regulations and guidance.

Evaluated Standard Operating Procedures in regards to process improvements and consolidation of procedures to eliminate redundant information (Technical SOP Writer).

Verified components and documentation according to blue prints manuals for the approvals of cleaning and set up for packaging production lines.

Provided technical support and troubleshooting in Packaging Quality issues.

Performed Corrective Actions and Preventive Actions evaluations using Trackwise software (CAPA).

Change Control for updates or modifications for standard operating procedures.

Technical Services experience in validation process (IQ, OQ and PQ) for packaging areas related to solid doses.

ISO9001

ISO9002

Quality Assurance Technician

June 2003 to April 2006 Baxter Transfusion Therapies KM 0 8 HM 3 Carr 357 Maricao, PR 00606. 787-***-****

Certificated components for packaging lines according to PCS, BOM, Blue Prints and incoming sop's.

Certificated, approved and Reconciliated of printed components.

Ozone Concentration Test (Titillation) every twenty-four hours (Lab technician).

Performed monthly audit completed for packaging improvement process, safety and SOP's.

Process audit and document review (Batch Record Review).

Take parameters and assurance quality levels.

Followed procedures and specifications according to the rules of current GMP's, FDA, TUV, ISO and OSHA.

Provided technical support and troubleshooting in Packaging Quality issues

Finished Good Material Test (Appearance, Strength, Dimension and Volume)

ISO9001

ISO9002

Education

2008 - 2012 Iberoamerican University, Santo Domingo, Dominican Republic

Medical Doctor

1997 - 2002 Inter American University, San German, Puerto Rico

B.S. Biology: Biomedical Sciences

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