Food Safety Manager

BHUMI GANDHI

** ***** **** ******* **, Budd Lake, NJ 07828

484-***-**** addoz5@r.postjobfree.com

EDUCATION

**** - **** ************ ***** **********, PA, USA

Bachelor of Science, Microbiology – 172 Credits

2011-2015 Pennsylvania State University, PA, USA

Minor in Chemistry

2007-2010 Veer Narmad South Gujarat University, Gujarat, India

Bachelor of Science, Microbiology

PROFILE:

●Exceptional analytical and report writing skills

●Excellent team player

●Studious and hard-working individual

●Proven fast learner, multitasker and ability of meeting deadline from past experience

●Strong organizational and interpersonal skills

●Good Math skill

●Knowledge of Computerized system and experience with Microsoft Word, Excel and Access databases

Highlights:

HACCP, PCQI, and Food Defense certified

cGMP, cGLP

Document Control

Corrective Actions and Preventive Actions/ Deviation System

FDA and FSMA Regulation

Dietary Supplement

Risk Analysis

Product Investigation

QC Microbiology

Chemical Control Program and Sanitation Program

Microsoft Office

LIMS/ComlianceWire/Veeva

Vendor Approval Program

PROFESSIONAL EXPERIENCES:

Microbiology Lab Supervisor (August 2019- May 2020)

Vitaquest, West Caldwell, NJ, USA

Oversees the daily operations of the QC Labs’ microbiology department.

Supervise the lab's microbiologists and provide guidance and training as necessary.

Keeping track of received raw material, in-process and final product samples for testing and Performing microbiological testing of of these samples and addition to that tesing of stability, probiotic testing, and Allergen Testing for the QC Laboratory.

Hands on experience of the data being pulled, pull testing data from LIMS, pull data, data entry, data consolidation, Assist, and making protocols submitting as per customer requirements.

Closely follow the environmental monitoring program and collect water samples and testing for Total Viable Count and absence of E.coli, P.aeroginosa, and Coliforms from the facilities using sampling SOP, associated document, and record the results.

Air Sampling using Agar plate and observe Total Viable count, and record the result.

Sterility check incoming media and perform Growth Promotion testing.

Effectively communicated the potential issues to management and associated group to meet highest level of accuracy.

Maintaining of analytical data within prescribed notebooks and reviewing and approving of other microbiologist’s lab notebooks and work to ensure daily logs and documentation within the micro lab meets current GMP compliance.

Reviewing and updating written procedures (SOP, STP etc.) and protocols when needed.

Investigate non-conformances of specifications, processes or material, then determines and drives CAPA completion.

Responsible for implementing installation qualification, operational qualification, and performance qualification of new instrument in Microbiology Laboratory

Implementing new or updated laboratory techniques for daily operations where required.

QC and Food Safety Manager (March 2019- August 2019)

Fratelli Beretta USA Inc. Mount Olive, NJ, USA

Responsible for the development, implementation, maintenance and improvement of the BRC/FDA programs.

Supervise QC Technicians to ensure QC activities are conducted in a correct manner throughout the plant.

Prepare the sample to send outside laboratory and release the products according to CoA.

Conducting environmental monitoring including ATP and Allergen analysis of the areas dedicated to the production and water testing in critical manufacturing & packaging areas.

Ensure the manufacture of products of the highest quality - outstanding in appearance, package presentation, performance and taste - by correctly handling and utilizing raw materials and Good Manufacturing, food Safety and Quality Practices.

Prepare and maintain product specifications, which meet customer’s requirements.

Provide national regulatory input and approval related to Change Control processes for artwork.

Develop a production program where finished product and critical control points are monitored and evaluated. Document and communicate results to production personnel and management.

Quality/Regulatory Affairs/ISO Specialist (April 2018- February 2019)

Nitta Casings, Bridgewater, NJ, USA

Reviewing, editing, and maintaining Quality Management System policies and procedures, Pre-requisite program, preventive controls and CCP’s for clarity, accuracy and compliance with US, Canadian and European regulations as well as ISO 9001, and ISO 22000

Perform all third-party audits to establish constructive working relationships with inspectors and auditors.

Ensuring facility and product registrations, product recalls and investigations were documented and maintaining appropriately to help ensure a constant state of inspection readiness

Providing regulatory guidance to product development teams and making strategic regulatory implementation via proper design controls throughout the product development process

Performing of pre-operational inspection to ensure safe and sanitary environment be maintained.

Work closely with warehouse staff to ensure compliance is followed.

Determining regional labeling requirements; reviewing and approving final labeling and packaging

Reviewing customer complaints for safety issues; non-conformances and CAPAs for effectiveness, Preparing investigational reports for field corrections

Leading on internal audits and issuing nonconformities to implement corrective actions for the completion.

Obtaining and managing required state, federal and international licenses.

Responsible to work closely with customer questionnaire and supplier documents to be approved.

Cross-function with Microbiology department.

Responsible for submitting reports on timely manner.

QA/ Regulatory Analyst (July 2016- April 2018)

Doehler North America, Pine Brook, NJ, USA

Identify compliance issues and areas for corrective/preventive action and follow up to assess the proper identification of problem cause and implementation of effective countermeasures

Responsible for the completion of all client requirements related to flavor product and/or material releases.

Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies and Assists the Director, QA by initiating, assisting with and/or reviewing quality product complaint investigations, regulatory and corporate inspections, non-conformance investigations, Corrective and Preventive Actions (CAPA), and extension requests.

Reviewing Equipment Validations, Master Batch Record Control, distribution and label verification

Ensuring of the safe release of flavor products in accordance with Teawolf and/or client procedures and requirements.

Authorizing and updating Standard Operating Procedures per company procedures, CGMP (Compliance with Good Manufacturing Practices); demonstrates adherence and compliance as a model for other colleagues to follow.

Preparation, revision and verification of manufacturing and pre-production and Post-Production Batch Records and responsible for Quality Assurance related support to various departments.

Tracking and trending of relevant quality records including environmental monitoring data.

Responsible for document, Supplier approval Program, and record control management and procedures.

Knowledge of food safety and QA programs and processes, Pest Control and Sanitation

Work closely with team members to develop recommendations on ways to improve the data capturing process.

Generate the CoA according to Customer requirement.

Recorded assessments electronically into a file review database

Knowledge of working with EDMS including LIMS and Smartsheet.

Attending everyday production meeting.

Perform internal documentation audits as assigned.

Cross-functional employees to be a back up for department activity.

All other duties assigned by the Manager

FSMA (Food Safety Modernization Act) with particular knowledge and understanding regarding preventive controls and FDA regulation.

Quality Control/Quality Assurance Technician (January 2016- July 2016)

Berk’s Food Packaging, Reading, PA, USA

Performing of environmental swabbing when required.

Preparation of broth and enriched media for Listeria analysis.

Generate daily, weekly, and monthly reports as well as other reports when requested.

Check foods for wide variety of factors and ensure compliance.

Inspect equipment prior to start up, for change- over, or when handling off to next shift.

Monitor product line setting and document check and issues found.

Calibrate equipment according to manufacturing standard and customer specification.

Conduct routine and spot inspection of materials, machinery, and production lines.

Analyze test results and drafted reports detaining and findings.

Updating of logs and records consistency to facilitate comprehensive information for review.

Following of all regulation and safety practices at all times.

Well Versed with GMP’s and SOP’s.

Strong knowledge and understanding of food microbiology, Food Safety/HACCP/HARPC, Sanitary design and controls, and food technology;

EXTRACURRICULAR ACTIVITIES AND INTRESTs:

Outdoor sports and recreation activities

Member of Indian Sub-Continent Association at Pennsylvania State University

Seminar on International Culture as presenting India

Presentation on Vaccinology and poster presentation on Antibiotic producing bacteria

Contact this candidate