Quality Assurance Specialist

To develop, implement, maintain the quality standard and systems of products and manufacturing process to ensure compliance with specifications, cGMP and FDA regulations.

• Responsible for implementing assigned tasks to improve quality system and performance (quality KPI)
• Maintain, implement, review and update SOPs to ensure federal regulations compliance
• Enforce SOPs implementation and conduct routine inspections on all departments to ensure procedures are strictly followed and executed
• Oversee training roadmap and progress required by GMP and job requirements to ensure all department staffs are able to effectively perform quality related duties
• Review and approve master production batch records and distribute to production department for mass production
• Review production batch records to ensure contents are filled in correctly and followed GDP, check and sign off production batch records and bin cards on the daily basis to ensure accuracy
• In charge of routine and non-routine analysis of in-process materials, raw materials, packaging materials, finished goods, stability samples, environmental samples and water sample
• Conduct in-process control (IPC) to improve production quality system
• Interpret test results, compare them to approved in-house specifications and control limits and make recommendations on appropriateness of data for release
• Conduct quality complaint investigation and perform simulation test to collect all necessary data for analysis, and use quality tools to analyze the most possible root cause and prepare reports
• Responsible for deviations, OOS, and follow up CAPAs until fully closed, and manage change controls in the timely manner
• Complete documentation needed to support testing procedures and validation protocols, including data capture forms, instrument logbooks, test solution and reference standard preparation records, and inventory forms
• Support QA department head for annual GMP audit preparation, CAPA implementation, and quality complaint investigations
• In charge of equipment calibration, maintenance records, and validation protocols (including 3Q documents)
• Ad hoc as necessary

• Education
  • Minimum Required: High School Diploma or GED and 5-years’ experience in a similar pharmaceutical, dietary supplement, or process food industry
  • Preferred: Associate’s Degree or B.S. Degree in Pharmaceutical, Chemical, or Biochemistry
  • 3+ years of quality management experience in the pharmaceutical, dietary supplement, or process food industry, and 2+ years of laboratory experience is
    preferred
• Specialized Knowledge
  • Knowledge of FDA regulation compliance for dietary supplement Knowledge of dietary supplement and pharmaceutical (OTC) manufacturing
  • Knowledge of specifications including raw material, semi-finished products, finished products, and packaging materials
  • Knowledge of cGMP, GDP, GLP, IPC, and/or QC7
• Skills
  • Computer Literacy: Proficiency in MS applications and databases
  • Analytical skills: Ability to analyze large amounts of data and determine deficiencies
  • Problem Solving: Problem investigation and solving for quality related issues
  • Inductive Reasoning: The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events)
  • Judgment & Decision Making: Considering the relative cause and effect of each production process
• Abilities
  • Able to communicate and work well with people on all levels of the organization
  • Able to receive, analyze and report out information efficiently
  • Ability to follow instructions and give instructions
  • Able to make recognize and apply general rules to specific problems
  • Must be proactive, listen carefully, patient, passionate, and highly responsible

This job operates in a professional office environment with exposure to the use of office
equipment such as computers, phones, and photocopiers. Working inside of the manufacturing
site is required to realize activities such as in-process testing.