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Charles City, Iowa, United States
Onsite
Job 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 monitoring data and reports. Participates in/ supports regulatory inspections as well as follow up action items. Perform batch record reviews and review of other records relating to processing of components, materials and finished veterinary biological for comparison with approved specifications and regulatory requirements.
Position Responsibilities:
• Tracking of Documents to ensure timely review to complete release on time.
• Review and approval of Standard operating procedures to maintain compliance.
• Perform assigned batch record reviews.
• Participate in the preparation for and execution of foreign and domestic regulatory agency inspections.
• Develop/revise, implement and maintain assigned Quality Assurance standard operating procedures.
• Audit manufacturing processes for compliance against approved regulatory licenses.
• Documentation review.
• Data collection for site Metrics.
• Support roles for all areas of Quality.
• Database review for support of release.
• Actively support, review, and approve of all manufacturing/environmental/ GMP deviations as well as related items (action items, commitments tracking, etc) related to manufacture of veterinary biological products at the Charles City, Iowa facility.
• Conduct walk through audits as part of the paint and patch process as well as ongoing construction activities being conducted at the site.
• Performs product related system dispositions based on local site procedures.
• Participates on in the Change Management process either as a team member or change agent.
• Participate in the preparation for and execution of foreign and domestic regulatory agency inspections.
Education and 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.
Physical Requirements
• Must be able to walk, sit, or stand for long periods of time.
• Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.
• Must be able to work scheduled 40 hours with the ability to work overtime as needed.
• Frequent lifting and carrying of 5 to 25 lbs.
• Regular reaching, bending, stooping, and twisting.
• Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
t of the wrists, hands, and/or fingers.
Full time
Regular
Colleague
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