Quality Assurance Specialist

1 week ago

San Diego, California, United States Simply Biotech Full time
Job Description

Overview

Simply Biotech is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing operations.

Key Responsibilities

  • Manufacturing Support: Provide technical support to manufacturing teams to ensure compliance with quality systems and regulations.
  • Quality Systems Support: Ensure the proper documentation, investigation, impact and risk assessments, corrective / preventive action plans, monitoring and trending for quality systems are completed in compliance with internal SOPs and current regulations.
  • Deviation Control and Execution: Control and execute deviations in accordance with company procedures and regulatory requirements.
  • Corrective/Preventive Action (CAPA) Plans: Develop and implement CAPA plans to address quality issues and prevent recurrence.
  • Investigations (INV), Out-of-Specification (OOS), and Out-of-Limit (OOL) Trends and Results: Investigate and trend OOS and OOL results to identify root causes and implement corrective actions.
  • Change Controls: Implement and manage change controls to ensure compliance with regulatory requirements.
  • Nonconforming Materials: Manage nonconforming materials and implement corrective actions to prevent recurrence.
  • Environmental Monitoring Excursions: Investigate and correct environmental monitoring excursions to ensure compliance with regulatory requirements.
  • Oversight and Support of GMP Manufacturing Activities: Provide technical support to manufacturing teams to ensure compliance with GMP regulations.
  • Cleanroom Activities: Perform cleanroom activities, including observing for extended periods and performing line clearances.
  • Reviews Production Batch Records and Associated Data: Review production batch records and associated data for product release, ensuring compliance with cGMP regulations.
  • Reviews Data Obtained for Compliance Specifications: Review data obtained for compliance specifications and report abnormalities.
  • Internal and External Audits: Participate in internal and external audits to ensure compliance with regulatory requirements.
  • Preparation and Support for Internal Audits: Prepare and support internal audits to ensure compliance with regulatory requirements.
  • Ensure Accurate and Timely Resolution of Quality-Related Activities: Ensure accurate and timely resolution of quality-related activities.
  • Communicate Issues and Assess Their Impacts: Communicate issues and assess their impacts, collaborating with others to resolve/mitigate those issues.
  • Update Management on Activities: Update management on activities, providing input and recommendations as appropriate.
  • Perform Alternate Functions: Perform alternate functions as trained within the company.
  • Other Duties as Assigned: Perform other duties as assigned.

Requirements

  • Bachelor's Degree in a Relevant Scientific Discipline: A Bachelor's degree in a relevant scientific discipline is required.
  • Knowledge and Understanding of Microbiology/Scientific Terms and Terminology: Knowledge and understanding of microbiology/scientific terms and terminology are required.
  • Knowledge of 21 CFR 210 and 211 and Other Related Regulatory Entities: Knowledge of 21 CFR 210 and 211 and other related regulatory entities is required.
  • 2-5 Years' Experience in the Pharmaceutical Industry or Relevant Experience in Another FDA-Regulated Industry: 2-5 years' experience in the pharmaceutical industry or relevant experience in another FDA-regulated industry is required.
  • Basic Computer Skills Required: Basic computer skills, including spreadsheets, MS Word, and Outlook, are required.
  • Ability to Lift 30 lbs. and Move Heavy Objects: The ability to lift 30 lbs. and move heavy objects is required.
  • Ability to Work from a Standing Position for Prolonged Time Periods: The ability to work from a standing position for prolonged time periods is required.
  • Regular Stooping, Kneeling, Bending, or Crouching: Regular stooping, kneeling, bending, or crouching is required.
  • Frequent Communication Hearing/Speaking/Writing in English: Frequent communication hearing/speaking/writing in English is required.
  • Ability to Problem Solve, Think Critically, and Troubleshoot While Working Independently: The ability to problem solve, think critically, and troubleshoot while working independently is required.
  • Ability to Communicate Clearly and Precisely, Both Orally and in Writing: The ability to communicate clearly and precisely, both orally and in writing, is essential.

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