Quality-focused professional in pharmaceutical manufacturing with hands-on laboratory testing and quality assurance expertise. Ensures compliance with FDA and GMP standards, enhancing product quality and safety through collaborative teamwork. Committed to continuous improvement and delivering exceptional results in high-pressure environments.
Overview
19
19
years of professional experience
Work History
QA/QC Laboratory Technician
Believer Meats
04.2025 - 12.2025
Upstream and Downstream Laboratory Testing and Analysis, conduct routine lab tests to assess product quality, including chemical, microbiological, physical tests and document results in company system to ensure compliance with internal and external regulations( FDA,USDA, GMP)
Performed real-time in-process quality inspections for upstream and downstream operations, identifying and reporting deviations from standard operating procedures to maintain quality control criteria.
Conducted raw material and product sampling, cell counts, and biochemistry assays, ensuring adherence to established quality standards.
Monitored production floor quality standards, ensuring compliance with protocols and contributing to overall product safety.
Review executed and master batch records, deviations, and associated CAPA plans for completeness and compliance.
Hands-on experience with cell-culture biotech and biochemistry analysis and use of laboratory equipment, pH, Conductivity meter, Flex machine, Microscopes, Micropipette,Plating etc..
Utilized aseptic technique and aseptic gowning for sampling handling in a controlled environment.
Cleanroom Operator/Process Technician
Phononic
10.2024 - 04.2025
Identify and verify the correct wafer type for each process, maintaining strict attention to detail.
Processed work orders in batches, achieving accuracy and meeting deadlines.
Safely handle chemicals in accordance with established safety protocols and guidelines.
Loaded and unloaded equipment with precision, preventing damage to products and equipment.
Followed standard operating procedures (SOPs) to ensure consistent, high-quality production.
Work with FRT Tools for measurements, pre, mid, and post measurements.
Sanitation Operator
Pfizer Pharma
11.2023 - 09.2024
Mixed required chemicals according to procedures to form cleaning solutions, completing all chemical concentration monitoring as described in procedural manual.
Handled spills in work and common areas and used proper methods to clean and sanitize each material.
Inspected final products to assess compliance with quality standards and established tolerances.
Demonstrated proper use of equipment to newly hired employees to avoid workplace injuries.
Assisted machine operators in setup and operation of production equipment, contributing to streamlined production runs.
Collaborated with team to achieve production goals while training at least 2 new members each month.
Taught members line speed, feed product, perform line clearances as well as loading and unloading materials.
Packaged finished products and prepared packages for accurate shipping.
Worked with supervisor to coordinate workflow and updated daily production team accordingly.
Facilitated positive interactions with site managers, outside contractors, and junior on-site staff to enhance communication.
MQA Specialist II Qualified Trainer/SME
Fresenius Kabi
NC
07.2021 - 10.2023
Collected inspection, particulate matter, AQL, and re-inspection reject data to support investigation and compliance activities.
Identified and initiated deviations in production area, placed products on SAP hold, and executed action plan to address investigation and compliance activities.
Conducted AQL checks on product and ensured inspector and AQL qualification status.
Supports Validation projects with required data collection.
Assures SOP's and batch records define the steps necessary to complete task.
Provides additional support for batch record review and critical processing steps that meet production and release scheduling.
Calculated and reviewed SPC limits for filling operation and analyzed operations using Statistical Process Controls.
Performs Mean Kinetic temperature calculations (MKT).
Review all batch records and logbook entries.
Operator II
Thermofisher Scientific
NC
10.2020 - 06.2021
Operated machinery for loading, washing, and filling trays in a sterile environment. of tray loader, washer, and filler.
Checked and inspected vials during processing to ensure compliance with quality standards.
Tested product to verify adherence to quality and MWO specifications.
Aseptic Cleaning Grade A-D area meeting MQA sterile process.
Perform line clearance before product is processed in sterile environment.
Logged room entries and recorded duties, dates, and times to maintain accurate operational records.
Knowledgeable of SCADA, WFI,CIP, Media fills, Aseptic Techniques and gowning process, Interventions, Autoclaves, steam sterilization, filtrations, line clearance and inspection, freeze drying fundamentals, WFO, PWO.
UD Technician
DSM Dyneema
N.C.
10.2018 - 10.2020
Prepared for production using DSM Dyneema schedule by studying requirements, clarifying specifications, calculating calibrations, weighing components, assembling materials, and stocking supplies.
Monitored operation equipment conditions and adjusted settings to comply with production requirements.
Maintained equipment operation through troubleshooting, repairs, and adherence to operations guidelines to ensure compliance with production standards.
Perform sterilization and maintenance checks including cleaning out-of-place, cleaning in-place and servicing in-place.
Adhere to cGMP standard operating methods and legal regulations to maintain a safe and clean work environment.
Adhere to filing and filtering procedures while calculating dilutions, concentrations and yields.
Document all production efforts in appropriate logs, forms, reports and databases.
Participated in professional training programs to stay updated on industry practices. with professional training opportunities.
Enhanced organizational reputation by consistently meeting and exceeding performance expectations in daily operations.
QA Process Attendant-Supervisor Assistant
Alliance One Specialty Products
N.C.
07.2009 - 05.2018
Calibrate Lab testing equipment daily.
Documented and communicated moisture testing results to production supervisor and customers via email; conducted specific gravity testing on flavoring truck loads to ensure compliance with FDA regulations.
Created and maintained spreadsheets and Excel files for customers; recorded all Certificates of Analysis (COAs) for company records while operating SAP and QTRACs daily.
Testing Product in a timely manner, such as CO2, Brix, Sodium, Temperature specified by customer request.
Complied with food safety, quality, GMPs, and HAACP allergen/sensitizer regulations.
Collected samples of raw materials for testing and analysis., finished products, and ingredients receiving and sanitation tests.
Performing post sanitation testing to ensure that equipment is clean, and free of product and microbial contamination.
Packaging-Auditor-Virus VBF
Leiner Health Products
N.C.
03.2007 - 06.2009
Operated automatic solid-dose packaging equipment within a work team.
Performed line-specific duties including line check-in, in-process quality monitoring, equipment operation, work center cleaning, changeover, and material movement with high accuracy and efficiency according to established procedures.
Batch record specialist assured that all documents, required tickets, labels, sample requests, stability paperwork and additional testing requirements are included in the packaging.
Monitored and adapted to schedule changes multiple times daily, managing reworks and retrieving issued packages effectively.
Collected samples for quality inspection in designated areas and investigated customer complaint reports for follow-up actions.
Delivered reports to department supervisor for review and action..
Laboratory technician/Analytical chemist/QA/QC (Full Time) at Institute of Science and Technology, TaiyuanLaboratory technician/Analytical chemist/QA/QC (Full Time) at Institute of Science and Technology, Taiyuan