Sr. Quality Auditor
ProClinical is advertising a vacancy for a Senior Quality Auditor position with a leading pharmaceutical, biopharmaceutical, and medical device capability company. The organisation provides comprehensive platform capabilities in small molecule R&D and manufacturing, biologics R&D and manufacturing, and cell and gene therapy R&D. The Senior Quality Auditor will join this company in their office in Pennsylvania. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.
The primary senior auditor's function is to participate in all facets of audits and inspections - client, regulatory, internal, external and vendor/supplier. They will also provide support for the PHL QA, corporate QA operations, and management to implement regulatory strategies and ensure regulatory compliance.
- Conducting site client audits as directed by QA Management, to present overall quality systems and procedures, and handle audit responses in a satisfactory and timely manner.
- Documenting audit observations in MasterControl audit module.
- Driving closure of CAPA resulting from audits.
- Communicating with clients on compliance issues and corrective action surrounding PHL audits.
- Participating in regulatory and accreditation audits and inspections as directed by QA Management.
- Conducting internal, external, and vendor/supplier audits as directed by QA Management.
- Participating in the development of site and corporate compliance policies, procedures, and documents.
- Contributing to compliance projects and participating in corporate and site strategic meetings.
Skills and Requirements:
- 5 years of relevant experience or equivalent
- Masters' degree in a Science related field or equivalent experience.
- Preferred ASQ certification.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at +1 267-477-4800 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
£0.00 - £43000.00 per annum
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