Quality Assurance
Resume:
Roma Bharucha
**** **** **. *** #**** 267-***-****
Houston, TX 77064 *************@*****.***
QUALIFICATION SUMMARY: A quality assurance auditor with strong manufacturing & pharmaceutical experience and applied
analytical skills to continuous process improvement. Familiar with cGMP, GLP, ISO9001, ISO14001, Quality Control, Quality
Assurance, and Quality Audit and tests (i.e: Assay, Impurity, identity, color, wet chemistry, manual titrations). Experienced using quality
improvement tools like lean, six-sigma, statistical methods, and root-cause analysis, and safety standards like OSHA. Proven project
leader, great team player (cross-functional), and stress management skills.
CORE COMPETENCIES
Management: Leadership Skills, Quick Learner, Self-Starter, Multitasking, Well-Organized, Result Oriented, Limited Supervision,
Interpersonal and Time management skills, Verbal and written communication skills, Organizational skills.
Software: MS Office, Empower, SAP, Intellitrack, Trackwise, Tiamo, Buchi, QAD, Laser-fiche, and SharePoint
Manufacturing: Lean, Six Sigma, Kaizen, 5S, 8D, PDCA, CAPA
Instruments: HPLC, GC, UPLC, NIR, G3, KF, autotitrater, FTIR, pH, Densitometer, Specific Rotation, and UV-Vis
PROFESSIONAL EXPERIENCE:
• QA Auditor
PCCA, Houston, TX 02/2014-Present
o Lead product and department audits and reviewing documentations.
o Review and update SOPs, review relevant CFRs and intermediate statistics.
o Write and review quality approve batch records, logs, deviations, change controls, and OOS reports per SOP and cGMP
requirements.
o Training new employees on conducting an audits, reviewing processes, and investigation.
o Managing audits, SOP books/system, controlled quality documentation, and annual review.
o Monitor operations electronic temperature control system, product relabeling, and manage quarantined items and discard
processes.
o Designing and updating SharePoint site for quality department.
o Supervise and evaluate the performance of Quality Assurance members.
o Applied Fishbone Diagram to eliminate Special Causes and minimize Common Causes to implement corrective actions.
• QC Lab Analyst 04/2011-12/2013
Noramco USA (A Company of Johnson &Johnson), Wilmington, DE
o Test raw materials, in-process and intermediate API, and finished products and report results into SAP database.
o Develop and validate new test methods, and investigate test analysis.
o Troubleshoot and perform calibrations and maintenance on laboratory instruments.
o Train other QC analysts on test methods and instruments.
o Train QC Analysts for test method/products/processes verification for QC and validation for Quality Assurance.
o Write standard operating procedures, OOS report, deviation report, and analytical worksheet.
o Executed non-routine analysis for development and method validation purposes.
o Conducted stability tests on working standards and other solutions for method development.
o Review lab notebooks (i.e. solution prep, mobile phase prep, standards, etc), analytical worksheets, and trainings.
o Determine root causes for non-conformances, recommends corrective actions.
• Lab Technician/Analytical Chemist I 12/2010-03/2011
PharmaNet USA, Princeton, NJ
o Executed an analyst cross validation and preparation of samples for analysis and extraction.
o Understood proper procedures for use of laboratory equipment and robotic instrumentation.
o Maintained laboratory notebooks and other required documentation according to PharmaNet procedures.
o Performed calculations and demonstrated accuracy in preparation of solutions and critical dilutions (for standard spiking
solutions and Quality Control’s (QC)).
o Familiar with LC-MS instrumentation setup for sample analysis and understand integration parameters for analysis.
o Familiar with requirements for lab practices and documentation for regulated studies.
• Pharmacy Technician/Data-Entry Technician 10/2009-12/2010
Express-Scripts Inc., Bensalem, PA
o Prepared and verified prescription and refill orders while maintaining productivity and quality standards.
o Selected and retrieved appropriate medications, compounds and verify quantities, and prepared labels for bottles.
o Send order to Pharmacist for completion and verification.
EDUCATION: Bachelor of Science in Chemistry, Temple University, Philadelphia, May 2009
Graduate Certification in QA/RA, Temple University, Philadelphia, August 2013
Certified Lean Six Sigma Green Belt
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