Quality Assurance Lean Six

DARSHANA GUPTE

Readington, NJ

www.linkedin.com/in/darshanagupte

908-***-**** *.*******@*****.***

SUMMARY

Highly motivated microbiology professional with extensive experience in the Personal Care, Pharmaceutical and Healthcare industries with an expertise in Current Good Manufacturing Practices (cGMP), using aseptic techniques, and certified Lean Six Sigma Black Belt achiever and expertise in OSHA regulations. Wide experience in leading Corporate Social Responsibilities (CSR) related projects aligned with business needs. Analytical, results driven, and thrive on new challenges. Result oriented dependable team player, with demonstrated abilities to work in and motivate cross functional teams. PROFESSIONAL EXPERIENCE

CHANEL, INC, Piscataway, NJ 2004 – July 2016

Microbiologist, Quality Assurance/Quality Control

Performed Microbial Limit Testing on raw material, work-in process, finished products and DI water.

Responsible for Environmental monitoring (viable air, non-viable particulate and surface) of production facility. Maintained database, performed trend analysis, issued summary reports.

Prepared lab media, performed growth promotion and maintained ATCC stock culture.

Responsible for maintaining,IQ,OQ,PQ,PM program for all lab equipments.

Maintained inventory of critical laboratory supplies and reagents. Negotiated cost with vendors.

Responsible for cGMP training for employees and authored lab Manual of daily operation .

Wrote/ Revised SOPs, Test methods, and lab documentation as needed for cGMP compliance. Validation Projects

Validated Cleaning reagents utilized in the facility and Raw materials for toiletry and OTC products.

Validated Bactiflow instrument, for Rapid Identification of finished products for product release.

Conducted validation for new test methods and Cleaning products. OOS (Out-Of-Specification) Investigation

Conducted and reported OOS (Out-Of-Specification) investigations for microbial contamination issues which resulted in timely release of samples and cost of recalling of products. Developed Training Program

Designed a cGMP training program emphasizing microbial contamination in production which resulted in reducing the number of contamination occurrences.

Co-led the C-LEAN Initiative Project to implement zoning and gowning measures in the facility.

implemented plant wide sanitization program which resulted in improved quality, cleanliness, reduced product contamination and global alignment with industrial standards. Developed and implemented Programs

Implemented Environmental Monitoring (EM) programs which created a better understanding of contamination in the facility, achieved cost savings of $5000/year and met ISO 8 standards.

Participate in a Hazard Analysis and Critical Control Points (HACCP) and a microbial management program. Resulted in control of microbial contamination & product recall. Audit Participation

Assisted in regulatory audits- FDA and Health Canada- as well as outside sub-contractor audits. Safety Officer for QA/R&D Labs

Wrote safety SOPs, conducted safety audits, training, and investigations.

Developed work practices that reduce the potential accidents and reported to the leadership team. Corporate Social Responsibility (CSR) Led Green team:

Developed 30% Recycled Paper project. Implemented Fix-A-Leak water project-saved 1000 gallons of water and $500/year. Presented Energy efficiency plan with potential savings of

$126,500/year. Renewable energies. Implemented Green Purchasing practices for cost savings projects.

DARSHANA GUPTE

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www.linkedin.com/in/darshanagupte

908-***-**** *.*******@*****.***

EDUCATION

MT, Medical Technology (MT), Gujarat, India

BS, Bachelor of Science Major: Microbiology Minor: Botany, Gujarat,India MLT, Medical Technology, (high honors), Middlesex College, Edison, NJ CERTIFICATIONS

Clinical Laboratory Technologist (MT) - State of New Jersey ID#-120*******

National Board of Registry in Microbiology (MT,ASCP ) USA License #-037783

Clinical Research Associate (CRA)-Drug Development, Reg. Affairs at Mercer College, NJ

Corporate Social Responsibility (CSR) training given by Climate Reality Project, Miami, Florida

Certified Sustainability Professional Make an Impact: University of Bath London, UK

Certified OSHA 511: Occupational Safety and Health standards for the General Industry

Certified Lean Six Sigma Black Belt

Supply and Chains in Practice -University of Warwick, UK PROFESSIONAL AFFILIATIONS

Personal Care Products Council(PCPC)

American Society for Microbiology Forum (ASM)

Pharmaceutical Microbiology Forum (PMF)

International Society of Sustainability Professionals (ISSP)

Security and Sustainability Forum (SSF)

The Climate Reality Project (CRP)

ADDITIONAL INFORMATION

Instrument Proficiency: Steam Sterilizer, Microscan/Vitex 2, Miliflex/Aqua meter, Etube/API 20E, Genezyme 20 Spectrometer, Beta-BDNA probe machine, Bactiflow. Languages: Fluent in English, Indian (Hindi, Marathi, Gujarati) IT Skills: Microsoft Word, Excel, PowerPoint, LIMS Volunteer Activities

Elijah's Promise Food Shelter; Habitat for Humanity; American Red Cross; VVA Clothes Donation; Maharashtra Foundation USA Charitable Organization Look Good Feel Better - Memorial Sloan Kettering Cancer Center ALS Foundation for Life: Walk to Defeat ALS

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