[Hiring] GMP Auditor @Intertek

Role Description

Intertek, a leading provider of quality and safety solutions, is actively seeking a Pharma, Dietary Supplement and Cosmetic GMP Auditor to join our Remote Business Assurance team. This is a full-time position, primarily responsible for performing GMP compliance supplier audits to assure that client’s 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.

What you’ll do:

• Plan, prepare, and conduct 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 evaluate potentially critical problems not covered by policies, standards, and regulations.
• Assess compliance with applicable FDA or country-specific regulations and guidelines, and/or the client’s 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 regulated processes are in compliance with applicable regulations and guidelines.
• 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.
• Manage and ensure all travel arrangements are in compliance with applicable travel policies.
• Maintain current knowledge of industry standards and expectations.

Qualifications

• Bachelor’s Degree in Chemistry, Biology, Engineering or related scientific field.
• Experience may be substituted for Bachelor’s 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 driver’s license and reliable driving record is required.
• This is a remote position; however, applicants must reside in and be able to legally work in the United States.

Preferred Requirements

• 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

• Ascend or descend ladders, stairs, ramps, and the like, using feet and legs and/or hands and arms.
• Stand for sustained periods of time.
• Walk, moving on foot to accomplish tasks and to move from one work location to another.
• Communicate well, through spoken word, conveying detailed accurate information & instructions to others.
• Hear well, perceiving sounds with or without correction, including the ability to receive information through 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 activities such as preparing & analyzing data, viewing a computer monitor, reading, report writing, visual inspection, and use of measurement devices.

Benefits

• Competitive compensation packages.
• Medical, dental, vision, life, and disability insurance.
• 401(k) with company match.
• Generous vacation/sick time (PTO).
• Tuition reimbursement.

Company Description

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. 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.

Intertek’s network of phenomenal people are our greatest assets, and the diversity they bring fuels our success. Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity.