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.
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