The Quality Operations Specialist is accountable for ensuring cGMP compliance within the site’s quality systems and is expected to identify and escalate areas of risk, provide guidance and support in the interpretation and enforcement of regulatory guidelines, and support site project initiatives. Primary responsibilities include: Customer Complaint handling, review and approval of Change Control documents, maintaining the site’s compliance with Zoetis Quality standards, review and approval of action items, commitment tracking items, Corrective and Preventative Actions (CAPAs) and interim reports, .
The Quality Operations Specialist will also assist in the support regulatory agency, customer and internal audits conducted at the site, provide support for market action activities and will assist in the identification and communication site and department metrics.
- Ensures cGMP compliance within the site’s quality systems
- Interpretation and enforcement of 9CFR, EU and other regulatory guidelines
- Provides guidance and support within cGMP systems for site colleagues
- Handling of customer complaints
- Support regulatory agency, customer and internal audits
- Review and approval of action items / commitment tracking items
- Review and approval of interim reports
- Support market action activities
- Support change management activities
- Assist in the review and assessment of Zoetis Quality Standards (ZQS)
- Collection and communication of site and department metrics
- Maintain department Standard Operating Procedures (SOPs)
- Other responsibilities as assigned
Governmental Regulatory Authorities
EDUCATION AND EXPERIENCE
Indicate the formal education, certification or license required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).
- BA/BS with 2-4 years of experience OR MBA/MS with 0-2 years of experience OR Minimum of 8 years relevant experience.
TECHNICAL SKILLS REQUIREMENTS
- Risk Management
- Investigation and Problem Solving
- Demonstrated technical capabilities
- Strong knowledge of local, federal and international regulations
- Organization skills
- Verbal and written communication skills (fluent in English)
- Proficient in Microsoft Office applications
- Attention to detail
- Demonstrated ability to work with internal and external colleagues
- 6-sigma or statistical skills (preferred)
PHYSICAL POSITION REQUIREMENTS
Lift materials up to 40lbs
Ability to sit, stand and walk
Some travel may be requiredFull timeRegularColleagueZoetis 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 [Register to View] 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 www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of [Register to View] 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.