Quality Assurance Control

Rashila Amatya

Rancho Palos Verdes, CA ***** 310-***-****

www.linkedin.com/in/rashila-amatya *******.******@*****.***

Quality Assurance Professional

Experience in quality improvement with background in Pharmaceutical industry and Biotech. Specialize in adapting to changes, opening opportunities to learn and develop. Attention to detail and data integrity. Proven ability to conduct meticulous documentation reviews, manage audits, and ensure adherence to global quality standards. Adept at collaborating with cross-functional teams to streamline operations, enhance product quality, and meet certification requirements.

Expertise

−CAPA

−Root Cause Analysis

−Regulatory Compliance

−Quality Management Systems (QMS)

−NCMR

−Risk Management

−Documentation

−Audits (Including Gemba Walk)

−Review of Raw Material and Finished Product Specifications

−Deviation

−Batch Record Review

Experience

HERBALIFE, Torrance, CA 2023 - 2024

Specialist, Quality Assurance (Scientist, Document Control) 2024

Scientist, Document Control 2023 - 2024

●Routed and implemented raw material change requests / orders in Agile, capturing approvals from different departments in a timely manner.

●Discussed specific country testing requirements with Global Regulatory Affairs and Product Compliance (Corporate and Regional), minimizing review time for cross-functional teams.

CEDARS-SINAI, West Hollywood, CA 2022 - 2023

Quality Assurance Lead

●Maintained and approved changes to cGMP documents and systems, aligning with regulatory requirements.

●Performed investigations, monitored corrective and preventive actions, and maintained change control system to comply with 21 CFR Part 11, lessening recurrence and guaranteeing system maintained traceability.

●Supported and led internal audit(s) for material handling, quality control, and manufacturing, preparing for regulatory / client audits, achieving compliance and company objectives.

Rashila Amatya *******.******@*****.*** Page Two

IMMUNITYBIO, INC., Culver City, CA 2021 - 2022

Quality Assurance Analyst II

●Performed real time documentation (batch record, logbook) reviews concurrently with manufacturing operations on manufacturing floor, providing Quality Assurance oversight in real time.

●Performed routine quality audits in Manufacturing, reducing audit ready time.

●Supported QA-related quality systems for in-process sampling and controls and aspects of shop floor, decreasing time and error for sending samples and receiving results.

NANTKWEST, El Segundo, CA 2017 - 2021

Quality Control Microbiology Associate

●Performed environmental monitoring, supporting manufacturing using aseptic technique and required protocol.

●Qualified for aseptic gowning Grade, guaranteeing ability to train cleaning crew, manufacturing, and quality control.

AGENSYS, INC, Santa Monica, CA 2017

Quality Control Senior Analyst II

●Performed release and stability testing of Non-Proteinaceous Impurities, completing reverse phase HPLC in conjugated BDS and DP using Thermo Scientific Ultimate 3000 HPLC.

●Used ELN for “On the Job Training” record, ensuring ease of accessibility via remote capabilities.

POLYPEPTIDE LABORATORIES, Torrance, CA 2008 - 2016

Quality Control Lead Chemist

●Approved raw materials in timely fashion, meeting production deadlines.

●Supervised staff and attended company-wide update meetings, reducing errors and increasing effective communication.

●Assisted with extension of raw material retesting, identifying stability based on structures.

●Educated and trained QC staff on amino acid analysis instrumentation and technology, exposing new hires to lab instruments and teaching duties of role.

●Performed release and stability testing of finished products, impacting final release, ensuring reliability.

●Handled customer audits, answered customer questions, and implemented CAPA for audits observations, providing SME for auditor.

●Reviewed, scheduled, and coordinated for IQ / OQ / PQ of various instruments, guaranteeing regulatory compliance.

●Developed and reviewed finished products and raw materials specifications and SOPs, adhering to regulatory guidelines.

●Reviewed data for various analytical testing, evaluating release and stability of finished products.

●Trained new hires and junior chemists to perform wet chemistry, HPLC testing, gas chromatography, and amino acid analysis, creating more competent new workforce and ensuring share of responsibilities.

Education

−Master of Science (MS), Chemistry, Tribhuvan University, Kirtipur, Nepal

Contact this candidate