Quality Assurance Supply Chain
Resume:
RGE
Rio Grande,
PR00745
Lic. Yolanda Hern ndez
Summary Due to the obtained experience working with regulated
companies, my knowledge, experience and skills makes me a great
asset for any organization.
Education
May 1986 Universidad de Puerto Rico, Rio
Piedras Campus
Bachelor in Science - Major in Chemistry
Minor in Mathematics
Colegio De Quimicos de PR
PR Licensed Chemist -3035
PR Plant Operator IV for Used and Potable Water Certification
(Passed and in Process of license release)
Experience 1999 - 2008 iPR Pharmaceuticals, Can vanas PR
Pharmaceutical Technologist
Generate and perform Validation Protocols as required
Generate and revise Standard Operating Procedures
Generate and revise Master Production Documents
CAPA fulfillment and closure
Deviations and investigations, generation and closure
Train all personnel that need to be trained to execute the
proposed protocols and procedures.
Performed as a project leader for several assignments.
QA Advisor
Participate in the required meetings to provide QA advise
Responsible for assuring consistency between the quality
systems for the new and the existing systems with decision
making during operations.
Review and approve documents (IQ, OQ, SOP, Exception Reports,
URS, CSV, etc) from manufacture, warehouse, laboratory,
maintenance and instrumentation areas.
Responsible to actively participate in the quality assurance
activities such as GMP refresher trainer and supply chain
sustenance activities ensuring compliance throughout all
assigned project phases.
Analytical Services and Development Group Chemist
Provide analytical support to Supply Chain, method transfer,
laboratory investigations, analytical troubleshooting.
Evaluate new Raw Materials suppliers for Alternate Suppliers
Project.
Perform analytical testing.
Issue Analytical methods and SOP revisions including the
provision of training to users.
Develop special protocols, analyze data and issue reports for
the evaluation of operational analytical changes including but
not limited to method equivalence, in-house method
modifications and compendia changes qualifications.
Certify and /or approve analytical reports when required.
Work in the Alternate Suppliers project as a core member.
1998- 1999 Jansen, Gurabo PR
Method Transfer Chemist
Products analytical methodology transfer from other company
sites to Gurabo facilities.
Physical and chemical testing of in process validation and
finished goods Products.
Assist the laboratory personnel on troubleshooting and training
of analytical testing or laboratory equipment.
Revise procedure and recommend necessary changes.
Use of data acquisition program (Millennium).
Verify analytical data conducted by laboratory personnel.
Data verification through LIMS system and write investigations
reports in concise manner.
1989 - 1993 EQ Laboratories, SJ
Lab Analyst
Wet Chemistry and Metals lab chemist specialist, performing
test to all kind of materials from Wastewater to sludge and
hard materials. Perform analysis to samples sent by
Pharmaceutical and other industries to determine the conditions
of their generated wastes and process waters.
Conduct analytical laboratory investigation report for any
unexpected results.
1986 - 1989 Colegio Espiritu Santo, SJ
Chemistry and Health Teacher
In Charge of Chemistry and health teaching for high school
students.
In charge of school choir..
Skills Good oral and written communications skills (English and
Spanish).
Able to adapt quick to changing conditions.
Self-starter and well organized with good interpersonal
communication.
Equipment calibration, preventive maintained and
troubleshooting skills.
Full knowledge of cGMP's
Computer literacy (Excel, Word, Power Point, Project,
TrackWise, Outlook )
HPLC, Spectrophotometers of UV/VIS, FT-IR, Atomic Absorption,
Karl Fisher, GC, Dissolution Baths.
Special Courses: Industrial Safety and Health, Project
Management and Problem Solving, Lean Management.
Contact this candidate