QA Specialist

zoetis; Charles City (IA); On-site; USD 65,000 - 90,000; Full time

Job summary

Zoetis in Charles City, Iowa seeks a Quality Assurance professional to review and approve GMP deviations, perform batch record reviews and support regulatory inspections. The role collaborates with manufacturing to maintain compliance, ensure timely product releases and uphold Zoetis quality standards across ongoing site projects.

The successful candidate will have CAPA training or experience, strong problem-solving and excellent written/spoken English, plus familiarity with SAP, Word, Excel and

Qualifications

• CAPA training and root-cause analysis preferred.
• Basic problem-solving skills.
• Excellent verbal and written communication in English.

Responsibilities

• Review and approve deviations related to GMP and manufacturing at the Charles City, IA site.
• Conduct audits during paint/patch and ongoing construction activities.
• Perform SAP dispositions per site procedures.
• Participate in Change Management as Quality SME.
• Prepare for and assist regulatory inspections and follow-up actions.
• Develop and maintain QA SOPs to ensure regulatory compliance.
• Review batch records and related processing records to support timely release.
• Audit manufacturing processes against internal/regulatory filings.

Skills

CAPA

Root Cause Analysis

Analytical Problem Solving

Communication

MS Office

Education

Bachelor of Science

Tools

SAP

Word

Excel

PowerPoint

Job description

Role Description

Position Summary: 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

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

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