Contract Opportunity - Senior OTC Compliance Auditor (Great opportunity for former FDA Inspectors)
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Job description
About the Position
We are SGS – the world's leading testing, inspection, and certification company. Recognized as the global benchmark for sustainability, quality, and integrity, we operate a network of 2,600 offices and laboratories with 99,600 employees working together to enable a better, safer, and more interconnected world.
We are currently seeking a highly experienced Contract Opportunity - Senior OTC Compliance Auditor with a background as a former FDA Investigator/Inspector. This short-term assignment (May-August 2026) requires expertise in OTC drug manufacturing, cGMP compliance, and FDA inspection methodology.
Responsibilities
- Conduct cGMP compliance audits of OTC drug manufacturing, packaging, labeling, and laboratory operations.
- Apply FDA inspection methodology to identify compliance gaps, risks, and deficiencies.
- Prepare detailed, professional audit reports outlining observations and recommended corrective actions.
- Support clients with mock FDA inspections, inspection readiness activities, and compliance remediation.
- Review quality systems, SOPs, batch records, data integrity controls, and laboratory practices.
- Represent the organization professionally during international client engagements.
- Manage scheduling, travel, and deliverables independently as an external contractor.
Requirements
- Former FDA Investigator/Inspector (required).
- 3–5 years of auditing experience within OTC or pharmaceutical manufacturing.
- Strong understanding of cGMP requirements, OTC monograph expectations, and FDA enforcement practices.
- Proven ability to conduct independent, high-level audits and articulate findings clearly.
- Excellent communication and technical writing skills.
Travel
- Must be willing and able to travel internationally, outside of North America, for the duration of the contract.
We Offer
- Opportunity to work with a global leader in testing, inspection, and certification.
- Short-term contract with potential for future engagements.
- Competitive compensation.
About the Company
SGS is an Equal Opportunity Employer, and as such, we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, and Indigenous status, or any other characteristics protected by law.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.
This job description should not be construed as an exhaustive statement of duties, responsibilities, or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.
Accommodations are available on request for qualified candidates during each stage of the recruitment process.
Please note that candidates applying for Canadian job openings should be authorized to work in Canada.
© SGS Portugal. This job description was sourced from the employer's public career page. TheJob is not the employer — we index the posting and route candidates to the source. All content rights and hiring decisions belong to the employer.
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