CONCEPCION VELEZ

Lakeland FL ***** admixu@r.postjobfree.com 787-***-****

Accomplished Quality Assurance Compliance Specialist Professional and Trainer with over 15-year experience in Pharmaceutical manufacturing operations, Retail Sales management, Electronics Manufacturing Management; successful QA Complaints Investigator specialized in QA Compliance & cGMP Regulations, and effective CAPA coordination and completion; QA/Quarantine Stockroom Management. Skills: strong prioritizing by handling multiple simultaneous priorities and meeting deadlines, analytical problem-solving; document control, office systems, QA Materials Management System; compulsive attention to details while developing and executing action plans, Standard Operational Procedures creation, translations, and Technical Writing including content review; QA Trainer; Document Control, Office administration and excellent communication skills.

PROFESSIONAL SUMMARY

Spanish-English Interpreter

Language Line Solutions - April 23, 2018 to present

Onsite, Consecutive Interpreter in the Health Care Industry and Customer Service

QA Compliance Investigator Specialist & Train-the-Trainer

Patheon Pharmaceuticals, Carolina, PR – 5 yr.

Completed internal and customer complaints' investigations lowering the review time by 25% in compliance with Food & Drug Administration Regulations.

Advanced Technical Writer & Content Review: Formulated Standard Operational Procedures (SOPs) in English and Spanish, document creation, translations, document review approval and training.

Report Writer: Annual Product Review; Monthly Quality Assurance Report; Plant Key Performance Standards (KPIs), to improve documentation standards.

Trained employees on SOPs and Federal Regulations to reduce the quantity of non-compliance events by 40%.

Developed the Quarantine Area with improvement of Standard Operational Procedures, which radically reduced the risk of questionable materials misplacement.

CAPA coordination and completion.

Member of QA Material Review Board to optimize approval and release of raw materials for manufacturing and product release areas.

Human Resources Executive Assistant & Training Coordinator

The Westin Rio Mar, Río Grande, PR – 7 yr.

Provided a new concept in quality of service to the Eastern area of the Hotel Industry in the Island; offered training and orientation on State and Federal Labor Laws to management staff.

Recruited management staff for newly opened resort, a Tishman branch Corporation in Puerto Rico, guiding the startup and management of a full spectrum of HR operations, systems, and programs.

Worked with executive management to create HR policies and procedures (English & Spanish).

Created group benefits databases; and develop orientation, training, and incentive programs.

Fostered a teamwork / open-door environment conducive to positive dialogue across the organization.

Personal efforts were cited as the driving force behind branch’s employee-retention rate of 89% within an industry where high turnover is the norm.

Compliance Investigations Specialist / Documentation Control & Release Specialist

ALCON P.R., INC., Humacao, P.R – 4yr.

Audited manufacturing and packaging modules (MPs, MSRs) - verification of document compliance and/or discrepancies for final product release.

Completed site investigations and facilities audits that had been pending.

CAPA coordination and completion - updated 4 yr. CAPA back up for 3 different manufacturing facilities. Monitored process and completion of all corrective and preventive actions.

Ensured all testing and documentation from QA and manufacturing data was complete and accurate prior to batch record approval and product release.

Project Management Assistant (Contract) – Reporting to Federal Affairs Director

Federal Affairs Office, Municipality of Luquillo – 1 yr. contract.

New Federal Affairs Office facilities complete rehabilitation and relocation within eight-month period (completion months prior to due date).

Information, Monitoring & Surveillance Center installation of equipment and service for the electronic surveillance of government facilities, tourist, and public areas.

Code of Public Order - re-implementation of the code in the municipality of Luquillo.

Spanish-English Interpreter for Mayor’s Office.

EDUCATION

BA, Business Administration, Major in Human Resources Management

Interamerican University at Fajardo Campus, PR, Summa Cum Laude - June 2010

COMPUTER SKILLS

MS Office, Word, Excel, PowerPoint, Publisher, Internet, Outlook, HRMS, Payroll & Quality Assurance Systems.

LANGUAGE - Advanced Level (both in English & Spanish)

Fully Bilingual - Having excellent communication skills: transcriptions, translations, and interpretations; performed book editing, and certified proofreader in both languages for over 20 yr.

PROFESSIONAL DEVELOPMENT

* MAPS System, Train-the-Trainer, Advanced Technical Writing, Proofreader’s Specialist Training

* How to Work Multiple Projects & Meet Deadlines, How to Be A Great Communicator

* Policies & Procedures Conference, Managers Training Seminar

* ADP, Advanced Documentation Training, OSHA Program Training & Administration

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