QA Specialist

6J6 - Zoetis LLC; Virginia; On-site; USD 70,000 - 90,000; Full time

Job summary

Zoetis Inc. seeks a Quality Assurance professional to collaborate with manufacturing colleagues as a cross-functional team member and approver of investigations, ensuring compliance with local policies.

Responsibilities include approvals of GMP deviations, audits of construction activities, and SAP dispositions. You will review batch records and related documents to support timely product release and participate in regulatory inspections, quality system SOPs, and CAPA processes.

Qualifications

• CAPA, Analytical Problem Solving and Root Cause Analysis training preferred. Basic problem-solving skills.
• Excellent verbal and written communication skills, fluent in English.
• Proficient with the following software programs: SAP, Word, Excel, and PowerPoint.

Responsibilities

• Actively support, review and approve of all manufacturing/environmental/ GMP deviations as well as related items (Visual mapping boards, action items, commitments tracking, etc.) related to manufacture of veterinary biological products at the Charles City, Iowa facility.
• Conduct walks through audits as part of the paint and patch process as well as ongoing construction activities being conducted at the site. Audits may consist of pre and post reviews as well as various system verifications.
• Performs product related SAP system dispositions based on local site procedures.
• Participates in the Change Management process as a Quality SME.
• Participate in the preparation for and execution of regulatory agency inspections.
• Develop/revise, implement and maintain assigned Quality Assurance standard operating procedures to ensure compliance with regulatory and quality standards requirements.
• Perform batch record reviews and reviews of other records relating to the processing of components, materials and finished veterinary biologicals for comparison with approved specifications and regulatory requirements as necessary to support timely release of product.
• Audit manufacturing processes for compliance against internal and regulatory filings (ZQS, PP, EU dossier, other markets).

Skills

CAPA

Analytical Problem Solving

Root Cause Analysis

Verbal Communication

Written Communication

SAP

Word

Excel

PowerPoint

Education

BA/BS with 0-2 years experience

BA/BS with 2-4 years experience

Tools

SAP

Word

Excel

PowerPoint

Job description

Role Description

Work with internal manufacturing colleagues as a cross functional member and approver of Zoetis investigations. Participates in production lab walk through audits prior/post construction projects as well as on-going maintenance activities requiring Quality oversite. Provides manufacturing floor support as needed to maintain compliance with local policies and procedures. Review and approval of Environmental and manufacturing investigations and reports. Participates in/ supports regulatory inspections as well as follow up action items. Performs product related system dispositions as necessary based on local site procedures. Perform batch record reviews and reviews of other records relating to processing of components, materials and finished veterinary biological for comparison with approved specifications and regulatory requirements, as necessary to support timely release of product.

Position Responsibilities

• Actively support, review and approve of all manufacturing/environmental/ GMP deviations as well as related items (Visual mapping boards, action items, commitments tracking, etc.) related to manufacture of veterinary biological products at the Charles City, Iowa facility.
• Conduct walks through audits as part of the paint and patch process as well as ongoing construction activities being conducted at the site. Audits may consist of pre and post reviews as well as various system verifications.
• Performs product related SAP system dispositions based on local site procedures.
• Participates in the Change Management process as a Quality SME.
• Participate in the preparation for and execution of regulatory agency inspections.
• Develop/revise, implement and maintain assigned Quality Assurance standard operating procedures to ensure compliance with regulatory and quality standards requirements.
• Perform batch record reviews and reviews of other records relating to the processing of components, materials and finished veterinary biologicals for comparison with approved specifications and regulatory requirements as necessary to support timely release of product.
• Audit manufacturing processes for compliance against internal and regulatory filings (ZQS, PP, EU dossier, other markets).

Education & Experience

• Associate: BA/BS with 0-2 years of experience OR Minimum of 6 years relevant experience. Specialist: BA/BS with 2-4 years of experience OR Minimum of 8 years relevant experience.
• Training in CAPA, Analytical Problem Solving and Root Cause Analysis preferred. Basic problem-solving skills.
• Excellent verbal and written communication skills, fluent in English.
• Proficient with the following software programs: SAP, Word, Excel, and PowerPoint.
• Excellent organizational skills and strong ability to multi-task.
• Willingness to positively embrace change and flexibility in adjusting to changing priorities.
• Strong attention to detail, ability to work well independently and as part of a team, and to work effectively with people at all levels within the organization.

Travel may be required Full time Regular Colleague

We have a strong commitment 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 [e-mail] 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 "@zoetis.com". 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.

At Zoetis, our purpose is to nurture our world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues’ careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.