Regulatory Compliance Auditor

1 week ago


San Jose, California, United States PSC Biotech Full time

About Us

PSC Biotech provides essential services to the life sciences industry, ensuring compliance with regulatory requirements. Our goal is to help clients achieve success through our expertise and global presence.

Job Description

We are hiring a QA Auditor to support the transition of a new CMO facility. The successful candidate will be responsible for conducting SOP audits, gap analyses, and staff training.

Main Tasks:

  1. Conduct thorough GAP analysis and auditing of standard operating procedures.
  2. Develop and implement quality recommendations for GxP processes and environmental monitoring procedures.
  3. Design and deliver high-level GMP training programs for staff members.
  4. Establish and maintain GMP processes that meet industry regulations and compliance standards.
  5. Provide technical guidance and support for program changes and execution.

Qualifications:

  • Bachelor's degree in a relevant scientific field.
  • Minimum 5 years of quality assurance experience in the pharmaceutical and/or biotech industry.
  • Strong understanding of cGxP regulations, EU regulations, and industry compliance.
  • Experience in quality auditing and GAP analysis.
  • Proven track record of reviewing and editing standard operating procedures.
  • Excellent communication and training skills.
  • Analytical and problem-solving abilities.

Salary: Estimated $45 - $60 per hour.



  • San Jose, California, United States Williams-Sonoma, Inc. Full time

    About the RoleWe are seeking a highly motivated and strategic Auditor Compliance Manager to lead our IT SOX program. This is an exciting opportunity for a seasoned IT audit professional with experience in leading teams and managing complex projects.Key Responsibilities:Lead the execution of the IT SOX program, including monitoring, application, and reporting...


  • San Jose, California, United States Top Group Full time

    Job OverviewWe are seeking an experienced Regulatory Compliance Professional to join our team. As a key member of our organization, you will be responsible for ensuring compliance with chemical regulations and managing regulatory requirements for the North American region.About the RoleThe successful candidate will have a strong understanding of chemical...

  • Compliance Auditor

    6 days ago


    San Diego, California, United States St. Paul's Senior Services Full time

    About the PositionSt. Paul's Senior Services is seeking a Compliance Auditor to join our team. As a Compliance Auditor, you will be responsible for ensuring that our organization is in compliance with all relevant laws and regulations.Salary Range: $80,000 - $105,000 per yearResponsibilities and QualificationsConduct ongoing audits, monitoring, and data...


  • San Jose, California, United States Top Group Full time

    Job OverviewWe are seeking a highly skilled Regulatory Compliance Professional to join our team as a North American Chemical Specialist. This is an exciting opportunity for a motivated individual to develop and implement chemical compliance policies and procedures, ensuring effective management of regulatory requirements across the region.


  • San Jose, California, United States PSC Biotech Full time

    Your RoleWe are hiring a Senior Quality Assurance Specialist to support the transition of a new CMO facility. As a key member of our team, you will perform gap analyses and auditing on standard operating procedures, providing quality recommendations and training staff members. Your expertise in GxP processes, environmental monitoring, and clean rooms will be...


  • San Jose, California, United States Top Group Full time

    About the JobWe are seeking a highly skilled Chemical Compliance Specialist to join our team in San Jose, CA. This role will involve developing and implementing chemical compliance policies and procedures to ensure effective management of regulatory requirements for the North American region.The ideal candidate will have a B.S. degree in Chemistry,...


  • San Jose, California, United States Ventura Solutions LLC Full time

    About the OpportunityWe are looking for a highly skilled Quality Process Validation Engineer to join our team at Ventura Solutions LLC. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our products.Main Responsibilities:Develop and refine Standard Operating Procedures (SOPs), processes, and procedures to...


  • San Jose, California, United States Adobe Full time

    Role OverviewThe Senior Director of IT SOX Compliance and Operational Audit will lead the company's compliance with Sarbanes-Oxley (SOX) requirements for IT services and systems. This role is responsible for supervising non-SOX IT and cybersecurity operational audits.About the JobLead a comprehensive SOX IT compliance program, including scoping and planning,...


  • San Jose, California, United States Gener8, LLC Full time

    Responsibilities:Manage one or several concurrent contracts and budgets with annual revenues up to $15M ensuring financial accountability and profitability. Oversee the execution of contracts, ensuring compliance with FDA, ISO 13485, and client-specific requirements.Provide technical expertise to understand project-critical functions, specifications, and...


  • San Jose, California, United States Adobe Full time

    About the JobWe are seeking an IT Audit and Compliance Manager to join our team. The ideal candidate will have experience in IT audit and compliance, and be responsible for developing and implementing policies, procedures, and controls to ensure adherence to regulatory requirements.Key ResponsibilitiesDevelop and implement policies, procedures, and controls...


  • San Francisco, California, United States Crowe Full time

    Your career at Crowe can be a journey of growth, innovation, and impact. With flexible work arrangements, you have the freedom to balance your work life with personal moments, delivering results that matter. We value diversity, care for your well-being, and foster an environment where everyone has equal opportunities for career advancement and...


  • San Jose, California, United States TEKsystems Full time

    Job DescriptionAt TEKsystems, we're seeking a seasoned Technical Product Manager to join our team. As a key member of our Retail Online portfolio, you'll play a critical role in ensuring compliance with regulatory requirements.You will work closely with stakeholders to identify and prioritize compliance needs, translating complex legal requirements into...


  • San Francisco, California, United States Unreal Gigs Full time

    Job SummaryWe are seeking a skilled Regulatory Compliance Expert to join our team at Unreal Gigs. In this role, you will be responsible for developing and implementing RegTech solutions that automate compliance processes such as AML, KYC, and GDPR. You will work closely with compliance teams, software engineers, and business leaders to design and deploy...


  • San Jose, California, United States Adobe Full time

    About the RoleWe are seeking a Senior Director to lead our IT SOX Compliance and Operational Audit program. The ideal candidate will have experience in leading distributed teams and driving significant change. They will be responsible for developing a comprehensive SOX IT compliance program, including scoping and planning, policies, procedures, and controls,...


  • San Francisco, California, United States Crowe Full time

    About CroweCrowe is a global professional services firm dedicated to helping its clients achieve their goals and improve their performance. With over 80 years of experience, we offer innovative solutions in audit, tax, and consulting that deliver excellent service through innovation.Estimated Salary: $90,000 - $120,000 per yearJob DescriptionWe are seeking a...


  • San Francisco, California, United States Unreal Gigs Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Compliance Expert to join our team at Unreal Gigs. The successful candidate will be responsible for ensuring the company's cloud infrastructure aligns with regulatory standards and industry best practices.The estimated salary for this position is $130,000 per year, based on industry standards and...


  • San Diego, California, United States CorDx Full time

    Job OverviewWe are seeking a highly skilled Regulatory Specialist to join our team at CorDx, a leading biotech organization. As a Regulatory Specialist, you will play a crucial role in ensuring the compliance of our In Vitro Diagnostic (IVD) products with regulatory requirements.The ideal candidate will have a strong understanding of FDA regulations, ISO...


  • San Jose, California, United States Hireio, Inc. Full time

    Job OverviewHireio, Inc. is seeking a highly skilled Compliance Risk Management Specialist to join our team.Estimated Salary: $80,000 - $100,000 per yearAbout the RoleThis role involves overseeing compliance with SOC standards, managing data security initiatives, and leveraging compliance management software and tools to ensure adherence to SOC reporting...


  • San Francisco, California, United States FM Global Full time

    FM Global is a leading property insurer of the world's largest businesses, providing more than one-third of FORTUNE 1000-size companies with engineering-based risk management and property insurance solutions.Schedule and Work ScheduleThis is a US-based In-Office position working out of our corporate headquarters located in Johnston, RI five days a week in...


  • San Diego, California, United States CorDx Full time

    We are seeking a highly experienced Regulatory Compliance Manager to join our team at CorDx. As a key member of our quality assurance team, you will play a crucial role in ensuring compliance with FDA and other regulatory agencies' requirements. Your expertise in ISO 13485 and other relevant standards will be essential in maintaining our quality management...