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  • Category: Science
  • Education: Bachelors Degree
  • Employment Length: fulltime
  • Pay / Salary: $21 Hourly
  • Source: Business
  • Ad #: 7118
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Regulatory Compliance Specialist - Yorba Linda, CA

Position summary: The QA and Regulatory Compliance Specialist will assist the Regulatory and Quality Systems Manager for DaVinci Biosciences, DV Biologics and The BioBox.  The Specialist will support all aspects of QA and Compliance, perform routine QA procedures, review and verify QC operations and records, and ensure adherence to ISO 9001 standard and compliance with applicable regulations – particularly 21 CFR 1271, cGTP, GDP, and GMP for both 361 and 351 HCTPs.

Schedule/Shift: Mon.,-Fri, 7 AM - 4 PM

Pay Range: $28-40/hr depending on experience

Essential Duties and Responsibilities:

  • Review lab notebooks, batch records, and QC records in order to verify certificates of analysis and QA documentation for proper approval of the release and shipment of our products
  • Maintain vendor/supplier qualification, review material specifications, and effect proper QA release of materials received for in-house lab and production use
  • Review and revise our existing libraries of SOPs, Forms, and Product Information
  • Identify and draft new SOPs, Forms, validations, and other documents as needed to maintain adherence with ISO 9001 and compliance with applicable regulations
  • Implement/monitor/enforce lab policies, process improvements, environmental monitoring, GDP, and employee safety
  • Assist with managing/recording customer complaints and implementing appropriate corrective and preventive actions
  • Participate in conducting internal audits, preparing deviation reports, and investigating/documenting CAPAs as assigned
  • Work with scientists and production staff to continually improve compliance and documentation – to ensure quality and efficiency
  • Assist with drafting data capture tools and writing reports in support of regulatory submissions

Job Requirements:

  • Bachelor’s/Master’s in a basic science (cell biology, molecular biology, biochemistry, clinical laboratory science)
  • 2+ years of work experience in regulatory compliance (certifications are preferred) in academia or industry
  • 2+ years of work experience in QA, QC, or the development and implementation of a Quality System
  • Understanding of requirements for cGMP, GTP, and GDP compliance, in addition to adherence to ISO 9001 standard
  • Demonstrated clarity and careful attention to detail in documentation, as well as in oral and written communications
  • Experience with laboratory management – employee and environmental health and safety, clean room requirements, and laboratory equipment maintenance – technical trouble-shooting and problem-solving skills are a plus
  • Working knowledge of standard scientific, analytical, and statistical principles
  • High standards of organization, time management, integrity, and work ethic
  • Ability to work under supervision, follow priorities, and provide leadership in a team environment
  • Ability to take direction, ask questions, take responsibility and work independently on routine tasks
  • Commitment to quality, accuracy, efficiency, and communication
  • Ability to work proactively in a roll-up-your-sleeves environment
  • Self-motivated and willing to learn and grow with a small company
  • Proficient in Microsoft Office Suite and Adobe Acrobat Pro

For Immediate consideration and any questions, please call Shardae at 714-971-0721 today!

Map: Yorba Linda CA
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