PROFILE: I am a highly motivated professional with ASQ-CQA certification and extensive experience in quality control and quality assurance, knowledgeable in cGMP and compliance, experienced in analytical testing and pharmaceutical industry. Experienced in nonconformance, out of specification and CAPA investigations with manufacturing process control/improvement projects. AREAS OF STRENGTH:
Experienced in Quality Control and Quality Assurance.
Experienced in using Quality Tools (Root Cause Analysis, Flow charts, Control chart)
Proficient in writing and reviewing technical documents including SOPs, Validation Reports, Work Instructions and Training guides.
Facilitating NCMR (Non-Conforming Material Reports) and CAPA investigations and Root cause analysis.
Final review, disposition, and release of Batch Records.
Proficient in interpreting data and specifications from compendia (USP and EP).
Knowledgeable in CGMPs, FDA CFR Parts11, 210 and 211 Regulations.
Experienced in Change Control, Quality Systems and Audits.
Dedicated Sr Lead Quality Control with 10 years of experience spearheading laboratory quality oversight and regulation enforcement. Seasoned professional at leading equipment validations, investigations and documentation. Focused on driving continual improvements through assessment and proactive problem-solving.
Skills
MS Office, Quality Management software like LMES (Laboratory Method Execution Software), LIMS (Laboratory Information Management System), CIMS (Consumable Inventory Management System), EDMQ Author access, and other instrument software like DU800, Tiamo, WinLab, Cary WinUV, LABMan SE, Class VP7.0
Analyst, TOC
Analytical skills, Troubleshooting
CONCEPT, Validation
Continuous improvement
Data management
Decision making
Detail oriented
Forms
FTIR
Functional
GLP
HPLC
Inventory Management
Leadership
LIMS
Managing
Materials
Presentations
Problem solving
Progress
Protocols
Quality Control
Quality Management
RECEIVING
Safety
Scientific
Specification
Staff development
Project planning
Problem resolution
Time management
Decision-making
Standards creation
Calibration skills
Inventory purchasing
Product development
Experience
08/2015 to Current
SENIOR QC CHEMISTApex Systems – West Palm Beach, FL,
Draft and revise SOPs, Validation Protocols and Reports, Work Instructions, and other controlled documents.
Conduct document changes via efficient change control process for SOPs, Log Forms and Training guides.
Interface on continuous basis with cross functional departments (e.g., Validation, Quality Engineering, Facilities, Manufacturing, Regulatory Affairs, and Quality Control) to assist investigations and to assure compliance.
Initiate Out of specification investigation and related nonconformances, deviations Investigations, along with proposed CAPAs.
Support Audit readiness initiatives.
Participated in internal and external audits for cGMP, GLP and Safety.
Performed Analytical Method development and Method validation for Zinc Oxide Analysis.
Experienced in troubleshooting analytical test instrumentation issues.
Perform Raw Material Standard qualification.
Perform Analytical tests using HPLC, AAS and TOC analyzer regularly as part of In-process and batch release process supporting manufacturing operations.
Perform FTIR and UV-Vis Spectrophotometer analysis for incoming raw materials.
Established procedure to track daily and weekly schedule and progress.
Performing data trending activities including trending of all data generated in the analytical lab related to batch production.
Working on continuous improvements in the operating procedures and document logs.
Management/Lead Experience:.
I perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.
I can effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines for self and motivate others to do the same.
I have demonstrated strong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing multiple projects simultaneously.
I represent quality department for Safety leadership committee.
Safety Leadership team orchestrates programs that ensures safe working environment for the organization.
I have been participating in continuous improvement programs on leadership and staff development.
06/2013 to 06/2015
CLINICAL QUALITY CONTROL/ASSURANCE ASSOCIATEAMGEN – City, STATE,
Performed routine, non-routine analytical testing and assays for in-process and stability samples.
Performed verification requirements and assessments to support new raw material specifications.
Executed visual analysis, Impurities testing (Limit tests for heavy metals, Lead, Arsenic, Iron, chloride, sulfate etc.), gravimetric test (LOD, ROI, ROE), pH, moisture content determination using Karl Fischer titration as well as non-compendia test methods to support the Raw Material testing.
Operated specialized equipment such as Osmometer 3250, Agilent Cary 60 UV-Vis Spectrophotometer, Beckman Coulter DU800 UV-Vis Spectrophotometer, Instron 5500 Materials tester for raw material samples, drug substance and drug products testing.
Ensured the timely disposition or release of tested samples like raw materials, drug substance, drug products.
Contributed and assisted cross functional teams for continuous improvement projects.
Performed inventory management of all in-house reagents and reference standards.
Contributed as team member for scrap reduction project in the laboratory -Work on minimizing the waste generated in the lab.
Created One-point lessons for laboratory issues, performed Monthly Issue tracking and prepared for lab audits and inspections.
05/2011 to 06/2013
ANALYTICAL LABORATORY ASSOCIATEHUDSON ANALYTICAL – City, STATE,
Analyzed elements using Perkin Elmer ICP-OES 8000(ICP-OES) and Perkin Elmer Analyst 200 Atomic Absorption Spectrometer (AA spectrometer).
Experienced in testing water for process use.
Interfaced with production team regarding chemical solution issues.
Maintained records and logs using data management software LabMan SE.
Assisted in preparing the lab for audits and review of laboratory operating procedures.
Maintained chemical inventory for laboratory.
Received chemicals and prepared chain of custody forms.
WILL BE RECEIVING ASQ SIX SIGMA GREEN BELT CERTIFICATION IN
: - , GPA:
Expected in 2007
ASSOCIATE OF SCIENCE: BIOTECHNOLOGY MOORPARK COLLEGE - , CA GPA:
GPA: 4.0
Dean's List Honoree 2007
Expected in 1996
MASTER OF SCIENCE: Microbiology University Of Mumbai - , GPA:
3.4 GPA
Expected in
COMPLETED KAIZEN BLITZ FOR CONCEPT AND APPLICATION OF LEAN: 8 TYPES OF WASTE: - , GPA:
Additional Information
AWARDS AND ACADEMIC ACHIEVEMENTS
, On Dean’s list in Moorpark college -2007
Top ranked in Master of Science in college.
Awarded the Best Performer of the year in the Executive Category (Win-Medicare Ltd), 1999.
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School Attended
MOORPARK COLLEGE
University Of Mumbai
Job Titles Held:
SENIOR QC CHEMIST
CLINICAL QUALITY CONTROL/ASSURANCE ASSOCIATE
ANALYTICAL LABORATORY ASSOCIATE
Degrees
ASQ-CQA CERTIFIED (Cert. No: 71713, Expires:
<ul><li>CERTIFIED IN SCRUM FUNDAMENTALS</li><li>WILL BE RECEIVING ASQ SIX SIGMA GREEN BELT CERTIFICATION IN</li></ul>
ASSOCIATE OF SCIENCE
MASTER OF SCIENCE
COMPLETED KAIZEN BLITZ FOR CONCEPT AND APPLICATION OF LEAN: 8 TYPES OF WASTE
