Remote GMP Auditor

Pharmaceutical Dietary Supplement and Cosmetic GMP Auditor - Remote

Intertek a leading provider of quality and safety solutions to many of the worlds top-recognized brands and companies is actively seeking aPharma Dietary Supplement and Cosmetic GMP Auditorto join our Remote Business Assurance team. This is a fantastic opportunity to grow a versatile career in GMP Auditing

Interteks Business Assurance team goes beyond testing inspection and certification to look at the underlying elements that make a company and its products successful. Our assurance solutions provide confidence and total peace of mind that a clients operating procedures systems and people are functioning properly to provide a competitive advantage in the is continually innovating and evolving to reduce risk for consumers brands and organizations in every sector and industry around the go beyond Testing Inspection and Certification of products: we are a Total Quality Assurance Provider to industries Purpose: Bringing quality safety and sustainability to life.

What are we looking for

This is a full-time position with the person primarily responsible for performing GMP compliance supplier audits to assure that clients products have been manufactured tested handled and stored in compliance with applicable FDA or other country specific regulations and client specific requirements. This position will travel at least 50% to 75% of the time.

Salary & Benefits Information

Individual compensation packages are based on a variety of factors unique to each candidate including skill set experience qualifications and other job-related reasons.

In addition to competitive compensation packages when working with Intertek you can expect benefits including medical dental vision life disability 401(k) with company match generous vacation / sick time (PTO) tuition reimbursement and more.

What youll do:

• Plan prepare and conduct of facility audits in support of GMP as directed.
  • Create Audit Plans and Agendas and send to site;
  • Hold Opening and Closing Meetings;
  • Interview and observe operations in situ.
• Assemble and coordinate the activities of the audit team.
• Interpret policies standards and regulations and then evaluates potentially critical problems not covered by policies standards and regulations.
• Assess compliance with applicable FDA or country specific regulations and guidelines and/or the clients requirements and specifications.
• Advise office immediately of any critical observations identified during audit.
• Ensure that written procedures are followed and exercise judgment in evaluating quality systems processes procedures and protocols for compliance.
• Review SOPs to ensure procedures and systems used in the regulated processes such as manufacturing and testing are in compliance with applicable regulations and guidelines including documented procedures for OOS recalls deviations complaints CAPA QA responsibilities batch record review and batch disposition.
• Appropriately escalate any compliance issues.
• Communicate audit results to management and auditees through written audit reports.
• Draft and Submit Audit Report for internal review.
• Manage post-audit activities (e.g.: CAPA assessment and review) and follow up on any necessary corrective and preventive actions by resolving any conflicts.
• Manage and ensure all travel arrangements are in compliance with applicable travel policies.
• Maintain current knowledge of industry standards and expectations.

This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties.

Minimum Requirements & Qualifications:

• Bachelors Degree in Chemistry Biology Engineering or related scientific field.
• Experience may be substituted for Bachelors degree:
  • Associate degree plus minimum of 2 years pharmaceutical manufacturing packaging or laboratory experience; or:

  • High School diploma/GED plus minimum of 6 years pharmaceutical manufacturing packaging or laboratory experience

• Valid drivers license and reliable driving record is required.
• Routine demands of an office-based environment.
• This is a remote position; however applicants must reside in and be able to legally work in the United States.

Preferred Requirements & Qualifications:

• Quality Auditor certification
• A minimum of 5 years actively participating in a GMP lead auditor role; supplier auditing experience
• Previous project management experience working in an ATIC environment is an advantage.

PHYSICAL REQUIREMENTS:

This role requires the ability to:

• Ascend or descend ladders stairs ramps and the like using feet and legs and/or hands and arms. Body agility is emphasized.
• Stand for sustained periods of time.
• Walk moving on foot to accomplish tasks and to move from one work location to another.
• Communicate well thru spoken word conveying detailed accurate information & instructions to others.
• Hear well perceiving sounds with or without correction including the ability to receive information thru oral communications.
• Exert up to 10 pounds of force occasionally and/or negligible amounts of force frequently to lift carry push pull or otherwise move objects.
• Have close visual acuity to perform an activity such as preparing & analyzing data viewing a computer monitor reading report writing visual inspection and use of measurement devises.

Intertek: Total Quality. Assured.

Intertek is a world leader in the Quality Assurance market with a proven high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. With passion pace and precision we work to exceed our customers expectations while engaging with our employees to be 10X in their performance and professional growth.

Intertek is a drug-free workplace. As a condition of employment certain positions may be required to pass a pre-employment drug test based on the type of work that will be performed.

We Value Diversity

Interteks network of phenomenal peopleare our greatest assets and the diversity they bring fuels our success. Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity. We take affirmative action to ensure all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability veteran status or other legally protected characteristics.

For individuals with disabilities who would like to request accommodation or who need assistance applying please email call 1- (option #5) to speak with a member of the HR Department.

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