KRUTI PATEL

Fremont, CA 925-***-**** ad3o47@r.postjobfree.com LinkedIn

SUMMARY

Dedicated and detail-oriented professional with 3 years of experience in Quality Assurance and a master’s degree in Regulatory Affairs. Possesses excellent organizational skills, effective communication abilities, and a strong commitment to maintaining high-quality standards in a collaborative and fast-paced work environment. Working experience and knowledge in GMP, ISO 9001, ISO 13485, and QSR.

SKILLS

Software Skills: Enzyme.com, Blue Mountain Regulatory Asset Manager, Smartsheet, MasterControl, NetSuite, DocuSign, 21 CFR Part 11 Compliance Adobe sign

Quality Skills: Document control procedures, ISO 13485, ISO 9001 Audit Procedures, Batch Records, GMP, QMS, QSR, CAPA, NCMR, SCAR, COA (Certificate of Analysis), 21 CFRs, Change Control/Order, Deviation. PROFESSIONAL EXPERIENCE

Vector Laboratories Newark, CA

QA Specialist 05/2023 – Present

• Facilitate the seamless transition of Document Change Orders (DCOs) through the approval process.

• Leading comprehensive training in EQMS/EDMS MasterControl, ensuring adherence to ISO 9001.

• Quality tracking by reviewing non-conformance material reports (NCMRs) with the Material Review Board

(MRB).

• Collaborated with cross-functional teams to establish and maintain Standard Operating Procedures (SOPs) for quality assurance.

• Subject Matter Expert (SME) of Equipment management, guaranteeing compliance with ISO and QSR requirements through oversight of Validation/Calibration/PM programs of more than 500 equipment.

• Articulate findings and recommendations clearly, both in written reports and verbal presentations.

• Working on the company’s Batch Release and disposition in NetSuite ERP including review of 100+ Batch Records.

• Led the introduction of a new Supplier Management Process, overseeing the assessment and monitoring of 200+ vendors in AVL and NetSuite ERP.

• Developed and implemented streamlined review procedures for Batch Records, Deviations, CAPA (including effectiveness check), and Change Controls, resulting in a 30% reduction in approval time and improved efficiency while ensuring strict compliance with quality requirements.

• Assist in reviewing and approving Validation Protocols and Process Verification Protocols.

• Executed internal audit and periodic inspection and participated in customer audit and ISO 9001 audit. Mammoth Biosciences Brisbane, CA

Quality Associate II 07/2021- 03/2023

• Monthly reporting of key quality performance indicators for management review.

• Managed company’s training matrix monthly and achieved nearly 100% company-wide training performance.

• Developed Quality Training Plans (QTPs) to assign training on several SOPs and WIs and created quizzes for SOPs as a part of training.

• Assisted in equipment quality management system (Blue Mountain Regulatory Asset Manager – BMRAM) and sustained equipment calibration and Preventive Maintenance schedule and records.

• Prepared NPS (Non-product Software) validation protocol and record for equipment management software.

• Reviewed and approved change requests of different documents in the company’s EQMS/EDMS (Enzyme.com) as a part of the document control procedure.

• Ensured that the quality assurance system is established, maintained, and monitored per relevant standards such as ISO 13485 and 21 CFR Part 820.

• Worked on different quality records such as complaints, NCR, SCAR, supplier self-assessment forms, etc.

• Owned supplier quality process and assessed existing 100+ suppliers as ASL (Approved Supplier List) in the company’s EQMS/EDMS.

InvaDerm Pharma Somerset, NJ

Regulatory Affairs Intern 01/2020-06/2020

• Trained in the compilation of regulatory documents for ANDA filing.

• Participated in on-floor QA activities such as reviewing logbooks, log sheets as per company compliance, auditing QC work, prepared stability schedules and handling of stability samples and release of batches.

• Assisted in reviewing BMR (Master Batch Records) of ANDA and OTC products.

• Performed and documented quality control checks to maintain compliance with company initiatives.

• Issued Batch records for production, Maintained the finished product batch records. EDUCATION

Master of Science in Regulatory Affairs of Drugs, Biologics, and Medical Devices 04/2019-04/2021 Northeastern University Boston, MA GPA-3.66

Bachelor of Science in Pharmacy 07/2013-06/2017

Gujarat Technological University, India GPA-3.7

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