Quality Management

Chetna Saini

BS Biochemistry Chicago, IL

Plainfield, IL 60544

******.*******@*****.***

Mobile: 630-***-****

SUMMARY

Experienced working with GLP, GMP, EPA, FDA, USP, USDA, FSQA, and ISO 17025 policies and compliance environment.

Led A2LA reaccreditation audit for Microbiology and Chemistry department.

Applied technical expertise to achieve 100% satisfaction on proficiency rounds from API (American Proficiency Institute).

Reduced laboratory operating expenses by 25% in collaboration with vendors and acquire new services for the laboratory.

Streamlined the documentation process during testing with a 50% reduction in documentation time.

PROFESSIONAL EXPERIENCE

EMSL ANALYTICAL, INC. (April 2015 – January 2017)

EMSL Analytical Inc. is an environmental testing firm, offering analytical testing services for asbestos, microbiology, lead paint, environmental chemistry, indoor air quality, industrial hygiene and food testing.

Microbiology Analyst/ Group Leader – Hillside, IL, USA

Key Responsibilities and Accountabilities:

Maintained the Quality Management System to comply with ISO, FDA and other regulatory statutes.

Revised and created lab SOPs, audited GLPs, and reviewed HACCP programs.

Oversaw Environmental Monitoring and sampling/testing to ensure non-compliance issues were kept to a minimum.

Managed projects including shelf-life studies, challenge studies, FDA import detention projects, matrix validations, and client-specific method validations.

Monitored Analyst’s lab work and provided mentorship on scientific and regulatory conduct.

Key Achievements:

Testing, Evaluation and Analysis: Tested equipment to ensure compliance; analyzed data and provided recommendations which resulted in adoption of new cost-saving equipment.

Project Management: Supervised project production efforts to ensure projects were completed to company standards, on time and within budget constraints.

Technical Customer Support: Designed challenge studies and shelf-life/ stability protocols to meet customer needs.

Statistical Analysis: Performed statistical analysis that resulted in recommendations for continuous improvements that were adopted at the national level.

Supplier Management: Worked closely with suppliers to ensure components met department quality standards to save on supply costs.

CERTIFIED LABORATORIES, INC. (June 2013 – April 2015)

Certified Laboratories Inc. is a private, independent laboratory providing services for environmental, raw material and finished product testing nationwide.

Lead Microbiologist – Bolingbrook, IL, USA (July 2014 – April 2015)

Contributed as a quality specialist in both internal and external audits.

Trained technicians’ in qualitative, quantitative, and diagnostic departments including the implementation of new methods and protocols.

Worked in conjunction with clients, client services and internal laboratory departments to meet client expectations and needs while maintaining quality standards.

Handled various non-conformance investigations (NCMR & CAR).

Performed monthly of culture maintenance, stock preparation, and organism identification.

Microbiology Technician – Bolingbrook, IL, USA (June 2013 – July 2014)

Performed aseptic sampling, plating, and testing of products under ISO 17025 and AOAC International Guidelines.

Prepared and reviewed the reports of microbiological analyses results for customers.

Consistently exceeded sample turnaround time goals by using time management skills.

Conducted both quantitative and qualitative analysis including sample homogenization, aseptic weighting of samples, plating, pouring, media preparation, and serial dilutions.

EDUCATION, TRAINING AND CERTIFICATIONS

Bachelor’s Degree in Biochemistry (2012)

University of Illinois at Chicago

The National Honor Roll (2008 – 2012)

Certificate of Honor for an outstanding academic performance

AFFILIATIONS

House Committee Member (2015 – Present)

Institute of Food Technologists, Chicago IL

COMMUNITY SERVICE

Active Volunteer

Sunrise Lake Outdoor Education Center, Bartlett, IL

Worked with a team to maintain grounds, repair structures, and build habitats for wildlife.

Active Volunteer

Hari Om Temple, Medinah, IL

Assisted in accomplishing tasks such as packing, serving and distributing food items during various events.

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