Navneet Kaur

Phone no. 925-***-****

(adtym2@r.postjobfree.com)

Summary:

Motivated, performance-focused, and detail-oriented professional with almost 7 years of specialized experience in Medical Devices, Health Care organization and Laboratories and hands-on experience into Technical writing & laboratory setting along with 1-2 years of interenship, volunteer experience in addition.

Extensively trained on Regulatory Quality Compliance and Clinical studies, GMPs, GCPs, GLPs and GDPs. Expert cGMP, CAPA, Risk assessment in specialist and OSHA specialist.

Looking for a rewarding career in an organization that values professionalism, integrity and offers significant opportunities for learning and growth to its employees.

Around 6 years of collective experience into QC & Technical Writing with expertise in QMS.

Educational qualifications:

Evaluated by the international education research foundation, inc.

Bundelkhand University, Jhansi, India.

Master of Applied Botany (MSc)

Guru Nanak Dev University Amritsar, Punjab, India.

Bachelor of Sciences (B.Sc.)

University of Kashmir, Jammu & Kashmir, India

Bachelor of Education (B.Ed.)

Professional Certifications & Participations:

1. Certified in OSHA Program (2022)

2. Certified Regulatory affairs/Quality Compliance specialist (2019-2020)-UCI DCE

3. 510(k) submission CERTIFICATES of attendance from OCRA-Sept-2019

4. Active Volunteer member -OCRA & ASQ (Orange County of Regulatory affairs)2020-2022

5. Certified in Quality Assurance Program, Kriger Research Centre International – Feb 2014

6. Certified Clinical Research Associate, Kriger Research Centre International – May 2013

7. Advanced Experience using MS word, Excel, Outlook, teams, spreadsheets, share point, Advanced knowledge using QMS QAD, ERP JDE, Jeves Intelex, B. Docs software’s,

Professional Experience:

Edward’s Lifescience Sep 2022 - Nov 2022

Sr.Regulatory Affairs Specialist/QA

Managed regulatory intelligence project on identifying ISO 13485 technical committee and working groups relevant to organization for the continuous improvement

Participated in global meetings for the Quality compliance and regulatory review to update China GMP regulations

Reviewed and edited the protocol for Issue identification for process improvement based on new regulatory updates as per ISO 13485, IEC 62304, ISO 14971,21 CFR 820.

Assisted team with preparing and review global MDD submissions.

Vit-Best Nutrition, Irvine, CA Apr 2022– Sep 2022

QA Technical Writer/Regulatory Affairs Associate

Working on maintaining regulatory audit files, reviewed MDRs, assisting preparing audit related paperwork, reviewing, and revising documents, working on label review, maintaining technical documentation,

Working on organizational development regarding Environmental health and safety rules, creating and helping with training content, trained companywide employees on cGMP successfully

Assisting in reviewing formulations for new product development, reviewing regulations to make necessary changes.

Vit-Best Nutrition, Irvine, CA Jan 2022 – Mar 2022

Technical Writer/Employee Development Specialist & Safety Champion

Working as a training specialist to train employees on Statutory trainings, documentation, compliance, safety and new revisions of docs to the concerned employees, as a Safety Champion helping management on decision making for the trainings required to keep employees safe, finding out safety issues at workplace for OSHA, creating and writing new safety policies for Employee development, Served as Liaison between OSHA, and cGMP safety Champion to resolve safety findings for Employee safety, worked on getting new instruments and prepared IQ, OQ, PQ for work safety and efficiency, keeping records updated for employee development

Assisting in writing Policies, training programs for safety, Ergonomics and maintaining records in QMS as centralized place for all record management. Creating and maintaining Training records, overseeing employee development for Training on revised documentation ensuring they understood training related changes. Led multiple learning programs to meet OSHA standards.

Vit-Best Nutrition, Irvine, CA Feb 2021– Jan 2022

Quality System Supervisor/Technical Writer

Maintained Doc. Control Quality System, Trained and Oversee Quality related activities, wrote and reviewed SOPs, Test methods, Policies as per 21 CFR 11,ISO 13484, QSR, ISO Updated all Documentation and prepared for Audits, served liaison to review Changes to implement compliance activities to per FSMA and FSVP, NSF compliance system, expert is QAD and QMS. Created and Implemented QSR regulated reports in QMS, worked closely with teams to Initiate and Implement Change Request, Process Improvement, Test method Validation for IQ, PQ, OQ, Served as Change Control board chairperson to conduct all meetings weekly collaborated with all departments and overseen CR impact on the teams, resolved all issues to implement changes on time, reviewed and maintained certs for regulatory and audit purposes.

Created Test Reports for QC to test Physical, chemical Heavy metal testing for biological contamination before use of raw material, Finalized and approved test reports in the QMS.

Regulatory and Compliance activities: Reviewed all protocols and policies for labelling to align with 21 CFR 111 system for dietary supplements. Maintained and updated records in QMS and updated all procedures to align with current practices.

B. Braun Medical. Irvine, CA Jun 2019 – Jul 2020

QA Remediations Specialist/ Technical Write

SOP Revisions - Worked as Author for writing and formatting SOPs for CAPA Remediation’s on change control and engineering design controls, projects to ensure quality meet all FDA regulations/Compliance. Actively worked with team on closing CAPAs and root cause analysis and CCRs for on ongoing projects & Assisted with Regulatory affairs for Change Request Initiation and Discrepancy Notifications.

Reconciliation projects- Maintained CDS (Clinical Data Sheets) for HPLC, GC and for stability testing and maintained QRFs (Quality review forms), conducted investigation to find root cause and completed auditing at initial to end level. EM project for risk assessment-Reviewed and worked closely with SMEs to designed new CDSs, generated new SOPs, rewrote new EM plans for more clarity and to ensure they follow FDA regulations. QAO (Quality Assurance Operations) for Chemistry Laboratory – Worked on product release for HPLC & GC Laboratory results, updated results on LIMS V7 (Lab ware system) to Release data on daily basis.

FDA Audits - Participated in resolving issues involved FDA submissions, audits, and compliance, Data retrieval support for FDA audits, actively supported in backroom for document compilation. Oversee internal and external quality audits and review findings with management performed different phases of FDA audits to maintain records for CDSs and supported team for FDA Compliance audits. Assisted with Complaints about product through root cause analysis by collaborating with R&D, Quality Control Labs, Manufacturing and Production departments to resolve issues and meet customer satisfaction

QRF data compilations for FDA audits and review and familiar with Project Management-Agile methodology.

Fujifilm Irvine Scientific, Irvine, CA Dec 2018 – Apr 2019

QA Product Release Coordinator

Worked to ensure quality of product by performing reviews of batch folder documentation to release product per QSR, ISO 13485.

Reviewed work as performed in compliance with established work instructions and adherence with SOPs including use of Device History Record (DHR) and assisted in activities related to preparation of controlled documents and conduct of FDA, Notified body inspections and customer audits for CE Mark. Assisted with Regulatory affairs as per Canadian, European and global level regulations to make, Initiated and Created and signed off all Certificate of Analysis (CoA) and reviewed processed Return Good Authorizations via software Intelex, Jeeves ERP System, Performed Inspecting on labeling and storage conditions of medical devices and medical products and complaint handling. maintained the non-conformance material log, files, and database, confirmed Change Control request initiated in required time.

Edwards’s life Science, Irvine, CA Jun 2015 – Mar 2018

Quality Control Inspector

Worked in collaboration with R&D departments, NPD (new product development) team and suppliers to reduce defects, Prepared Non-Conformances (NCR) of products by following SOPs (Standard Operation procedures), WO (work orders) per ISO 13485 and CFR 820 for GDP.

Worked on Review, Follow, perform job in compliance with established work instructions and adherence with SOP including use of Device History Record and entering information into Enterprise Resource Planning (ERP), JDE, Worked with Engineers for new product development and provided feedback & worked on QMS and EDMS on regular basis. Supported Quality Engineering activities to improve company quality objectives worked closely with Engineers and vendors for Complaints regarding product, participated in NPD for continuous improvement. Applied six sigma/lean methodologies for zero wastage of product.

Worked on Quality assurance, document verification of components to ensure adherence with Standard Operating Procedures (SOPs) and compliance with Regulations. Working experience in Receiving Inspection, reading, and interpreting Certificate of Analysis and Certificate of Compliance for Class III level.

VA Medical Center, Long Beach CA Mar 2014 – May 2015

Research Associate (volunteer position)

Clin Proxy Research Services Jul 2013 – Jul 2014

Clinical Research Associate (Intern)

Covidien, Irvine, CA Jul 2012– Oct 2012

Medical device Assembler (Production)

Antech Diagnostics, Irvine CA Feb 2011– Dec 2011

Laboratory aide

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