QA Specialist

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

Job summary

Zoetis, Inc. in Charles City, IA is seeking a QA professional to ensure GMP and regulatory compliance. You will review manufacturing/environmental deviations, approve investigations, and support regulatory inspections while maintaining QA documentation per site procedures.

The role requires strong English communication, attention to detail and proficiency with SAP, Word, Excel, and PowerPoint, with willingness to travel as needed.

Qualifications

• CAPA and root-cause analysis training preferred.
• Fluent in English with excellent verbal and written communication.
• GMP/QA experience preferred.

Responsibilities

• Actively support, review and approve all manufacturing/environmental/GMP deviations and related items.
• Conduct walks through audits of paint/patch processes and ongoing construction activities.
• Performs SAP system dispositions per site procedures.
• Participate in the Change Management process as a Quality SME.
• Assist in regulatory inspections and follow-up actions.
• Develop/revise QA SOPs to ensure regulatory and quality compliance.
• Review batch records and related processing documents for timely product release.

Skills

Verbal communication

Written communication

Attention to detail

Team collaboration

Education

BA/BS with 0-2 years experience

BA/BS with 2-4 years experience

Tools

SAP

Microsoft Word

Microsoft 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 timeRegularColleague

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 [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.