Compliance Auditor

  • location: Bradley, IL
  • type: Permanent
  • salary: $61,000 - $70,000 per year
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job description

Compliance Auditor

Randstad is seeking a Compliance Auditor for our client, a biotechnology production facility in Bradley, IL. The Compliance Auditor is responsible for:
1) Verifying that the facility is in compliance with cGMPs, international regulatory requirements and established internal policies;
2) Supporting regulatory authority inspections and conducting audits for the facility's internal auditing program;
3) Communicating compliance improvement recommendations;
4) Providing guidance and consultation regarding interpretation of regulatory mandates to the manufacturing site.

--Provide compliance guidance and support to site personnel, including cGMP training and communication regarding compliance issues, to internal business units.
--Perform independent review and approval of investigations (Deviations).
--Assist in site preparation for regulatory and customer inspections and participate in inspections.
--Remain current with domestic and international regulatory requirements and quality standards, i.e. PIC/s, EU law, WHO, FDA, etc.
--Conduct internal audits, including audits of regulatory submissions.
--Perform quality system audits of approved and potential suppliers/service providers against the identified standards i.e. ISO, CFR 820, ICHQ7, etc.)
--Prepare and maintain Quality Agreements for other company sites.
--Participate in site product recall activities.
--Develop and maintain technical and functional expertise in manufacturing processes and associated supporting quality systems.
--Participate in the material review and material change processes, as required.
--Support site KPI???s.
--Perform additional tasks, as assigned.

Working hours: 7:00 AM - 3:30 PM

--Ability to communicate with people at all levels of the organization.
--Detail oriented and extremely organized.
--Confident personality with the ability to deal with conflict and/or difficult situations
--Self-motivated with a willingness to learn.

--BS/BA degree required. Strongly prefer technical or scientific field. Audit Certification highly desired.
--Understanding of FDA and European Regulatory requirements.
--Must have relevant quality auditing and regulatory experience in a GMP or GXP related industry.
--3 years??? experience in a GMP or GXP regulated facility, with at least 2 years in a Quality role highly desired.
--Supervisory experience in a manufacturing setting is preferred.
--American Society of Quality certification is preferred.

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.

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