drjobs Quality Assurance Auditor

Quality Assurance Auditor

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1 Vacancy
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Job Location drjobs

Kalamazoo, MI - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Role Description

Anticipated Job Role Level (commensurate with education experience and skill levels): Senior Associate II Quality Assurance Auditor

EDUCATIONAL BACKGROUND/EXPERIENCE

MINIMUM:

Bachelors Degree or equivalent in biology animal science or other relevant science field.

DESIRABLE:

Masters degree or equivalent in biology animal science or other relevant science field.

WORKS EXPERIENCE/SKILLS

MINIMUM:

Demonstrated relevant quality assurance auditing experience (minimum 1 year) in veterinary medicine or related regulatory environment (e.g. GCP GLP GMP). Competency using Microsoft Office suite (e.g. Word Excel Outlook). Establishment of excellent interpersonal relations; good communications; ability to negotiate risk assess and problemsolve. Ability to work independently while fostering good working relationships across physical distance and have flexibility and the capacity to handle multiple tasks at once. Ability to travel if needed (515%).

DESIRABLE:

3 years working in a research quality assurance field supporting animal health trials. Proficiency in the understanding of current regulatory requirements regarding the quality of research for registration of animal products in major global markets. Proficiency in performing quality assurance audits and inspections of nonclinical and clinical veterinary product studies and reports (including protocols data/data listings statistics master study files final study reports clinical investigator study sites and inphase inspections) and of facilities CROs and processes that support those studies.

JOB DESCRIPTION

As a staff member within the Global Quality & Compliance group the

Senior Associate II Quality Assurance Auditor provides quality assurance oversight to the Veterinary Medicine Research & Development (VMRD) clinical and nonclinical programs.

Be proficient in the understanding of current regulatory requirements in regard to the quality of research for registration of animal products in major global markets. Proficient in performing quality assurance audits and inspections of nonclinical and clinical veterinary product studies and reports including: protocols data/data listings summary & analysis master study files final study reports investigator study sites and inphase inspections. Be proficient in performing quality assurance audits and inspections of equipment facilities CROs and processes that support nonclinical and clinical veterinary product studies. Participate in a variety of Quality Assurancerelated activities including staff and project meetings nonstudy document reviews and consultations with VMRD colleagues. May assume the lead role for various projects within GQC. Provide compliance training to VMRD staff and contractors. When requested participate in government inspections of clinical and nonclinical studies as well as pharmacovigilance and other inspection types (e.g. import/export permits).

Full time

Regular

Colleague

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Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at to request an accommodation. Zoetis also complies with all applicable national state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at site or (2) via email to/from addresses using only the Zoetis domain of @. In addition Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Employment Type

Full-Time

Company Industry

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