Regulatory Auditor

This is a remote position.

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special.

When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job it’s about your career and your future.

Your Role

We are hiring an experienced Auditor to join our team and contribute to our commitment to excellence and regulatory compliance, performing audits on behalf of our clients.

Travel is required. This is a W2 Temp or 1099 contract position.

• Plan, execute, and report on internal and external audits in accordance with GMP, GLC, FDA, ICH, EU, CFR, CFR 210, 211, 820, and other relevant regulations and standards.
• Travel domestically and internationally as needed to conduct audits and engage with clients.
• Assess compliance with company policies, procedures, and applicable regulatory requirements.
• Prepare comprehensive audit reports detailing findings, observations, and recommendations for corrective actions.
• Maintain accurate and detailed documentation of audit processes and outcomes.
• Communicate with clients to understand their specific needs and expectations.
• Provide guidance and support to clients on compliance issues and best practices.
• Stay abreast of current and emerging regulations in the life science industry.
• Ensure effective coordination and communication within the audit team.
• Additional responsibilities as required.

Requirements

• Bachelor's degree in a relevant field.
• Minimum of 5 years of regulatory auditing experience within FDA regulated industries.
• Advanced knowledge and expertise in GMP, GLC, FDA, ICH, EU, CFR, CFR 210, 211, 820, and other relevant regulations and standards.
• Bilingual proficiency is required for effective communication with international clients and regulatory bodies.
• Excellent technical writing skills.
• Strong interpersonal skills to interact with clients, team members, and regulatory agencies.
• Strong analytical and problem-solving abilities.
• Ability to make sound decisions in complex regulatory situations.
• Frequent travel is required in order to perform on-site auditing.

Equal Opportunity Employment Statement

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment.

Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination.

Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to : recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs.

Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived : race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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