Quality Manager Management

VANDANA PATIL

***** **** **** ****, ******* Texas • Mobile: 516-***-**** • **********@*****.***

1

SUMMARY

Accomplished Quality Manager with 15 years of expertise in the Manufacturing industry, specializing in Quality Management Systems (QMS). Demonstrated ability to lead teams across various functions, ensure regulatory compliance, and drive process improvements. Adept at managing quality processes, including complaint management, CAPA, design controls, and supplier oversight. Strong communicator with proven skills in both verbal and written formats. EDUCATION

B.S., Biology, SUNY College at Old Westbury, NY. May 2005 B.S., Microbiology, North Maharashtra University India. May 1999 PROFESSIONAL EXPERIENCE

Nurse Assist

Quality Manager 03/2022-Present

• Ensure the effectiveness and efficiency of the Quality Management System, ensuring compliance with FDA, Health Canada, and ISO standards.

• Expertise in quality process such as complaint management, CAPA, design controls, and statistical sampling plans and supplier management.

• Oversee quality laboratories, including in-process inspection, testing, OOS investigations, and stability studies.

• Lead training, document control, and records management.

• Manage supplier quality, including evaluation, assessment, and performance monitoring.

• Analyze and present quality data, support management review activities, and oversee production processes.

• Handle complaint investigations, adverse event reporting, and post-market surveillance.

• Interface with customers for complaints, manage SCAR and NC responses, and initiate CAPA activities.

• Support the development and review of QMS processes and documentation to ensure alignment with the scope of the QMS and existing certifications.

Nurse Assist

Technical Service Supervisor 09/2019-03/2022

• Initiated corrective/preventative actions (CAPA) as requested and follow up as needed.

• Directed CAPA initiatives and followed up on quality improvements.

• Effectively managed and developed quality team leads, analysts, and lab technicians.

• Oversaw lab operations to ensure product specifications and managed supplier qualification and periodic reviews.

• Oversaw stability program.

• Managed change control, document control, and cleaning validations.

• Participated in preparation and leadership of internal and external audits and inspections.

• Quality lead for implementation of new business system (CloudSuite Industrial). Nurse Assist

Quality Engineer 09/2018-09/2019

• Proposed and implemented process improvements to enhance compliance.

• Authored and updated procedures, led quality system components like Dose Audits and Stability Programs.

• Conducted data trend analysis and product/process investigations. VANDANA PATIL

11321 Bull Head Lane, Roanoke Texas • Mobile: 516-***-**** • **********@*****.*** 2

Beauty Manufacturing Corporation

Microbiology Laboratory Supervisor 07/2017-08/2018

• Managed non-conformance investigations and ensured adherence to SOPs.

• Trained personnel, evaluated methods, and performed water and microbial testing.

• Ensured effective operation through accurate scheduling and procedural updates. Mériux NutriSciences

Operations Supervisor 11/2016-07/2017

• Supervised departmental activities and communicated client requirements.

• Assisted with analysis tasks, maintained supplies, and ensured timely results.

• Collaborated with Operations Manager to address non-conformance issues. Miller Coors

Microbiologist (Contract Project) 07/2016 – 10/2016

• Performed microbial analysis on raw materials and finished products, ensuring compliance with SQF and cGMPs.

• Supported Packaging, Utilities, and Brewing departments in troubleshooting critical control points. PALL Corporation

Microbiology Laboratory Scientist I 11/2006 – 02/2016

• Trained and supervised microbiology associate scientists.

• Managed daily laboratory operations and applied advanced problem-solving techniques.

• Conducted GeneDisc® Rapid Microbial System testing for pathogens and spoilage microorganisms. Awards & honors

• Full Scholarship from NIMH

• Academic Achievement Award

• Achievement Award from Sigma XI Research Society

• Six Sigma Green Belt Certification

• ISO13485:2016 Lead Auditor Certification

• Leadership Certification

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