Biology and Physics Teacher @ Colegio Nuestra Senora de la Merced
Mathematics Teacher @ Fountain Christian Bilingual School
Ms. Ayala is a professional in the Pharmaceutical and Biotechnology industry. Provide technical support to operations bulk facilities. Understands the technical details of the process, including the scientific background, to monitor and evaluate performance and proactively recommend/take corrective actions, if needed. Partner with production and quality control to ensure process is safe and compliant. Experience gathering data
Ms. Ayala is a professional in the Pharmaceutical and Biotechnology industry. Provide technical support to operations bulk facilities. Understands the technical details of the process, including the scientific background, to monitor and evaluate performance and proactively recommend/take corrective actions, if needed. Partner with production and quality control to ensure process is safe and compliant. Experience gathering data and reviewing Annual Product Reviews (APRs) and Manufacturing Batch Records (MBRs). Experienced in cGMPs compliance and Quality Systems, such as investigations, non-conformances, policies and procedures. Knowledge in supporting business systems as TrackWise, Regulus, LIMS, Delta V and excellent knowledge in OSI PI. Knowledge in statistical concepts, such as Design of Experiments, Normal Distribution, ANOVA, Control Charts, Sampling, Confidence Intervals, cGMP, and FDA regulations. Bilingual (Spanish/English), individual leader, able to work under minimal supervision, well organized, excellent interpersonal skills, fast learner, highly inquisitive, resourceful and team worker.
Technical Consultant @ Process expert.
Provide technical support to operations of bulk manufacturing site.
Understands the technical details of the process, including the scientific background, to monitor and evaluate performance and proactively recommend/take corrective actions, if needed.
Partner with production and quality control to ensure process is safe and compliant.
Understand the Operational and own the Process Control strategy including key process parameters.
Ensure that the process is maintained in a validated and capable state.
Understand the QPPA and APR data and translate that for Process Team understanding.
Support daily operations using statistical tools and understand source of variability and continuously improve the process.
Own the batch records and revisions.
Own the process mass balance and potential sources of product losses, including waste.
Maintains and operate specialized equipments such as of BioProfile 300A. Perform analytical testing, characterization, method development, sample and data management. Monitors performance of equipment and tools.
Performs/guides/documents investigations and/or product analysis and corrective actions efforts, as applicable.
Process validation support.
Experience with Systems Application Product (SAP) Business Objects InfoView.
Assist with technical training to Operations personnel and support groups on unit operations and process. From January 2012 to January 2015 (3 years 1 month) Biology and Physics Teacher @ Conducting classes and giving instruction in a science subject
Supervising the students and monitoring their understanding of the subject by conducting timely examinations
Making arrangements for scientific workshops
Conducting laboratory classes to improve the practical understanding of the students
Assigning scientific projects for the students and ensuring that it is submitted within deadline
Assigning homework to the students in order to gauge the students understanding of the lecture given in the class
Giving feedback to the students after evaluating their performance
Keeping students updated about in scientific field
Attending seminars and workshops to keep updated about development in the field of science
Using various tools and equipments to give practical demonstrations
Responsible for providing an educational atmosphere where students have the opportunity to fulfill their potential for intellectual, physical and psychological growth.
Implements instructional activities that contribute to a climate where students are actively engaged in meaningful learning experiences.
Update and maintain all necessary records accurately and completely as required by laws, district policies and school regulations
Identifies, selects, and modifies instructional resources to meet the needs of the students with varying backgrounds, learning styles, and special needs.
Assists in assessing changing curricular needs and offers plans for improvement.
Maintains discipline in accordance with the rules and disciplinary systems of the school
Communicates effectively, both verbally and in writing, with students, parents, and other professionals on a regular basis.
Collaborates with peers to enhance the instructional environment.
Models professional and ethical standards when dealing with students, parents, peers, and community.
Ensures that student growth and achievement is continuous and appropriate for age group, subject area, and/or program classification. From August 2011 to December 2011 (5 months) Mathematics Teacher @ 1) Plan lessons as per the given curriculum.
2) Teach students in such a manner that they understand the subject and gain knowledge.
3) Assign home work, check them and give feedback to students.
4) Grade assignments and exam papers.
5) Give tips to students to improve their performance.
6) Help students in tackling math problems.
7) Complete a syllabus within an academic year.
8) Take the help of different props to simplify and explain complex math problems.
9) Teach arithmetic, fractions, decimals and geometry to elementary level students.
10)Middle school equations, graphs and statistics.
11) High school algebra, calculus, probability and trigonometry. From January 2011 to May 2011 (5 months) Independent Consultant @ From August 2009 to December 2010 (1 year 5 months) Jr Address Analyst @ Title 13 Confidential Clearance From March 2010 to April 2010 (2 months) Washington D.C. Metro AreaTechnical Services @ Support and take action in activities related non-conformance investigations and process assessments.
Maintain GMP Documentation and process manufacturing batch records (MBRs) updated.
Assist on Quality Product and Process Assessment (QPPA)
Annual Product Review (APR), data gathering and review
Use statistical process control charts for continuous process monitoring, process improvement, problem solving and analyze data for periodic metrics presentations of process performance and process trending.
Participate in scientific staff meetings, data review and site reviews.
Trained personnel in SOP’s and process documentation.
Process validation support. From January 2008 to July 2009 (1 year 7 months) Cooperative Education Student @ Participate in scientific staff meetings related to manufacturing issues and troubleshooting.
Assist in the preparation of manufacturing process overviews related to the inoculation, incubation, harvest and purification to be used as a reference guide during issue investigation.
Support and take action in activities related to the clinical protocols, non-conformance investigations and process assessments. From July 2007 to December 2007 (6 months)
Bachelor of Science (BS), Industrial Biotechnology @ University of Puerto Rico-Mayaguez From 2001 to 2007 SOLIMAR AYALA is skilled in: GMP, JMP, Batch Records, Biotechnology Industry, Pharmaceutical Industry, SOP development, Fermentation, Manufacturing, Isolation, Quality System, Change Control, FDA, Trackwise, Regulatory Affairs, Validation
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