QA Specialist

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

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