Summary
Overview
Work History
Education
Skills
Additional Information - Patent
Timeline
Generic

DRAGOS ALEVIZACHE

PLANO

Summary

Accomplished Quality Control Scientist at Lang Pharma Nutrition with expertise in regulatory compliance and quality assurance. Successfully improved operational productivity by over 20% through effective project management and process optimization. Proficient in HPLC and adept at fostering inter-departmental collaboration to drive product development and ensure adherence to FDA regulations.

Overview

21
21
years of professional experience

Work History

QUALITY CONTROL SCIENTIST

Lang Pharma Nutrition
Middletown
01.2024 - Current
  • Provides support for analytical testing of new and existing products
  • The position will also work with the QA Technical Support team to provide expertise for investigation of out-of-specification results
  • Work cross-functionally with the Scientific Affairs and Retail Development teams to evaluate and transfer testing methodologies for new and current ingredients and finished products
  • Interface directly with raw material suppliers to identify and transfer appropriate testing methodologies for unique ingredients
  • Interface directly with 3rd party testing laboratories to help identify and transfer appropriate testing methods for raw material and finished product, based on specific material attributes
  • Perform reviews of scientific literature and peer reviewed studies to assist in determining the most appropriate methodology for testing of raw materials and finished product
  • Act as a subject matter expert in support of the 3rd Party Laboratory Qualification Program
  • Author and provide subject matter expertise for Deviation, CAPA, Change Control, Investigation and Complaints as needed
  • Review and approve interim and completed product stability and shelf-life substantiation reports
  • Interface with retailers as needed, to provide subject matter expertise on testing related issues
  • Review and Approve formulations and specifications given by contract manufacturer
  • Set up overages for ingredients in a variety of formulations
  • Set up and review and approve master formulations sheets – ensure correct data calculations, overages practices, testing method codes and limits for critical parameters has been entered correctly
  • Used Quilty management software (Ensur) and Smartsheet as project and quality assurance management tool
  • Review and approve products specifications
  • Interface with manufacturers to troubleshoot OOS s or production related issues and help to decrease number of reworks or failure by making technical recommendations and /or solutions for continuous improvement and enable faster turnaround times
  • Perform other tasks and responsibilities assigned by the supervisor
  • Participate at on boarding new customer meetings and communicate effectively throughout the development process ensure samples meets customers’ expectations prior to product launch
  • Expertise in flavoring systems for solid and liquid dosage forms

DIRECTOR OF QUALITY

Lacore Nutraceutical
Van Alstyne
01.2018 - 01.2024
  • Lead and develop a team of 30+ employees within Regulatory, Compliance, Quality Assurance, and Quality Control
  • Implement, challenge, and maintain all process and procedures related to the internal and external Quality Management Systems for Dietary Supplement and Food Manufacturing Activities
  • Host all Customer and Regulatory audits to include FDA, State of Texas, NSF, Kosher, and Halal
  • Conducted Internal and external audits
  • Audited with zero non-conformances by maintaining compliance with regulatory requirements
  • Improved operational productivity rates by +20% and minimized maintenance expenditure by delivering hands-on training to staff members in the utilization of equipment
  • Reduced production defects by devising KPIs/parameters, establishing limits and criteria for failures, and developing Lot acceptance rates, rework rates, lab OOS, recurring quality event rates, and CAPAs
  • Obtained cGMP, Kosher, Halal, and Sports NSF certification within a span of one year while managing the integration of CFR 111 & CFR 117 protocols in the production facility
  • Optimized production processes by eliminating redundant steps and fine-tuning critical parameters, such as cross-contamination prevention, moisture control, and batch optimization
  • Ensure Corrective action plans are implemented through inter-departmental collaboration
  • Managed Vendor Qualification Program
  • Ensure the product quality lifecycle from raw material receipt to finished product release meets established specifications prior to release to market
  • Manage post-market surveillance activities and complaints
  • Drive inter-departmental collaboration with R&D and Operations for New/Existing product development and resolution activities
  • Re-Established internal laboratory operations for analytical and microbial testing which reduced external testing costs and decreased overall testing lead time
  • Created and maintain formal training program for company based on training matrix and individual training plans which ensures compliance with current regulations
  • Establish tracking and trending system for Deviations, Change Request, Non-Conformance, CAPAs, and Complaints to drive mitigation activities through data analytics
  • Elevated supplier performance by creating quality metrics of raw materials, equipment, supplies, and third-party testing
  • Implement SPC (statistical process control) devices to oversee the production downtime or productivity rates
  • Ensure that calibration and maintenance activities are completed by defined schedule
  • Used 6 Sigma to improve quality systems

DIRECTOR OF QUALITY

JW Nutritional
Allen
01.2011 - 01.2018
  • Manage quality compliance activities for dietary supplement contract manufacturing facility including complaints, change controls, document control, deviations, non-conformance's, out-of-specifications investigations, internal audit program, supplier assurance qualification, batch record issuance to production, batch release to market, raw material and packaging component release
  • Manage operation quality to ensure manufacturing activities were in compliance with customer specification by developing and guiding in-process inspectors on testing processes and quality adherence
  • Manage analytical and microbiological laboratory activities related to raw material testing, finished product testing, stability, qualifications of instruments, method development, and specification creation
  • Manage the regulatory department to ensure all site activities were in compliance with local, state, and national policies
  • Provide full review of labels to include claims, supplemental fact panels, nutritional fact panels ensuring compliance with FDA regulations
  • Maintain site registration with FDA, Health Canada, and state of Texas
  • Provide quality input to management meetings, site reviews, S&OP monthly planning, and guidance to all departments managers
  • Developed training program
  • Established SOPs for all departments
  • Worked cross functionally to ensure all procedure are followed
  • Collaborate with R&D and customer on new product development and existing product development activities
  • Review and approve all documentation related to technical transfer files from development to commercial activities
  • Approve all budget activities for quality department
  • Managed Vendor Qualification Program
  • Conduct Internal and external audits
  • Oversee internal laboratory activities for release raw materials, finished products and components
  • Create, review, approve and maintain SOP’s, Master Batch Records and Batch production records

CHEMIST II

Sovereign Pharmaceutical
Fort Worth
01.2010 - 01.2011
  • Employed purified water testing protocols to ensure stringent quality standards through continuous monitoring of system performance parameters
  • Maintained a secure laboratory environment by handling hazardous materials and adhering to safety protocols and regulatory guidelines
  • Managed instrument maintenance protocols, including routine part replacements, HPLC column cleaning, and OQ/PQ for HPLC and GC machines
  • Drafted and prepared detailed reports and presented to the clients for informed decision-making
  • Obtained actionable insights by commissioning comprehension of data analysis and statistical methods
  • Troubleshoot laboratory instruments for optimal functionality, safety compliance, and smooth operations
  • Exhibited exceptional proficiency in the development and validation of analytical methods for drug analysis that meet rigorous industry and regulatory benchmarks
  • Employed advanced analytical methodologies, such as HPLC, GC, AAS, TLC, UV-VIS, FTIR, Karl Fisher, wet chemistry, Automatic Titrators, melting point, Polarimeter, and GFAAS to analyze compounds and quantify elemental content
  • Coordinated with equipment manufacturers for contract-based maintenance and provided hands-on training to internal staff for tasks ranging from quarterly to daily calibration and system testing
  • Proficient on following USP, FCC, AOAC, JP, EP pharmacopeia monographs procedures for drugs and supplements

QC TECHNICIAN AND R&D COMPOUNDING & FLAVORING

Progressive Laboratories
Irving
01.2004 - 01.2010
  • Performed a wide range of formulation calculations by interpreting and analyzing laboratory data for valuable insights and process improvement
  • Applied in-depth knowledge in assessing the functionality of raw materials, encompassing amino acids, proteins, botanical extracts, fibers, and carbohydrates
  • Developed diverse flavor samples for a wide array of products, including proteins and pre/post-workout powder mixes for utmost client taste satisfaction
  • Carried out FTIR testing and established reference standards by demonstrating an ability to interpret spectral peaks

Education

BACHELOR OF SCIENCE (B.S.) - APPLIED SCIENCE & PHYSICS

Babeș-Bolyai University

Skills

  • Quality Assurance
  • Regulatory Compliance
  • Project Management
  • GMP
  • Quality Control
  • Laboratory Management
  • Method Development
  • HPLC
  • FDA Regulations
  • Process Optimization
  • Analytical Chemistry
  • Product Development
  • Microsoft Office
  • Quality Management Systems
  • Supplier Qualification
  • SOP Development
  • Risk Management
  • Audit Management
  • Cleaning Validation
  • Analytical data review
  • SPC
  • KPIs
  • Mixing Validation
  • R&D Formulations
  • Master Batch Records

Additional Information - Patent

Systems and Methods for Increasing Agmatine Cellular Uptake by Oral Administration, 9993447

Timeline

QUALITY CONTROL SCIENTIST

Lang Pharma Nutrition
01.2024 - Current

DIRECTOR OF QUALITY

Lacore Nutraceutical
01.2018 - 01.2024

DIRECTOR OF QUALITY

JW Nutritional
01.2011 - 01.2018

CHEMIST II

Sovereign Pharmaceutical
01.2010 - 01.2011

QC TECHNICIAN AND R&D COMPOUNDING & FLAVORING

Progressive Laboratories
01.2004 - 01.2010

BACHELOR OF SCIENCE (B.S.) - APPLIED SCIENCE & PHYSICS

Babeș-Bolyai University

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DRAGOS ALEVIZACHE