ALMA I RODRIGUEZ

Coral Springs, FL ***** 954-***-**** adkee3@r.postjobfree.com

PROFESSIONAL SUMMARY

Determined and detailed Quality Assurance Specialist with a dedication to quality and accuracy. Skilled in handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills. First-rate creative thinking, problem-solving and time management abilities. Committed to paying impeccable attention to reviews and auditing procedures. Ability to prioritize and multitask. Exceptional and clear communicator with good multitasking skills, organized nature, and strong attention to detail. SKILLS

• Materials inspection

• Correction action planning

• Production Optimization

• Detail oriented

• Responsible

• Good Manufacturing Practices (cGMP)

• Quality Assurance

• Corrective actions

• Technical troubleshooting

• Good Communications Skills

• Excellent Customer Service

• Proficient in English and Spanish

• Standard Operating Procedure (SOP)

WORK HISTORY

Quality Assurance Batch Record Reviewer, 01/2010 to 10/2020 Teva Pharmaceuticals USA – Davie, FL

• Determined overall product quality by accurately conducting a review of executed manufacturing batch records, Validation reports, Confirmation reports, QC testing, raw material records, Stability records and finished products batch records in a timely manner to comply with company and customers due dates and regulations.

• Verified and confirmed that the company's Standard Operating Procedures, Current Good Manufacturing Practices, Policies were properly followed.

• Revised accuracy of quality control testing for final release.

• Support site teams completing Validation and Confirmation lots to successfully development products and releases.

• Debugged code and located root causes of problems by reviewing files and logs.

• Reduced batch records pending review backlog from 60+ days to less than 10 days from the received day in QAMD department.

• Prepared QA evaluation reports and submitted to management.

• Prepared and revised meticulous reports base on FDA observations.

• Participated on presentations for company’s Senior Leadership visits.

• Increased and improved knowledge of JD Edwards, SAP, LIMS v.5 and v.7, Trackwise Harmony, software by engaging in all available trainings and seminars.

• Provided regular updates to team leadership on quality metrics, communicating consistency problems or production deficiencies with quality and production leadership.

• Effectively collaborated with QC laboratory and OPEX department, working closely to develop innovative solutions and opportunities for improvement to increase productivity and quality. Research and Development Technician, 05/2010 to 01/2012 Teva Pharmaceuticals USA – Davie, FL

• Reduced operational roadblocks and solved product and process issues to optimize efficiency.

• Inputted and edited computer entries from generated research.

• Handled all troubleshooting tasks on malfunctioning lab equipment working with team members to resolve problems.

• Assisted with training team members in laboratory techniques and operation of equipment.

• Reduced project discrepancies by optimizing quality control standards.

• Supported senior management with creation and enhancement of continuous improvement of research procedures.

• Kept all work areas extremely clean and sanitized properly to avoid errors in research.

• Coordinated with research and development team to support production and boost efficiency.

• Maximized efficiency by meticulously organizing and administering experiments.

• Followed research protocols when gathering data and performing lab experiments. Technical Writer, 10/2007 to 02/2010

Azopharma – Miramar, FL

• Analyzed and update instructions on batch records and necessary documentation base on costumers needs.

• Communicated with customer representatives for feedback and distribution.

• Proofread copy written by colleagues to correct spelling, punctuation, and grammar.

• Organized material to research and complete writing tasks.

• Edited batch records and documents and offered feedback to improve writing skills.

• Utilized exceptional writing, editing and proofreading skills to produce engaging and error-free content.

• Carefully documented technical workflows.

• Created and presented drafted batch records and other technical documents to complete packages. EDUCATION

Associate of Science: Administrative Assistance and Secretarial Science University of Puerto Rico - Humacao - Humacao, PR

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