(Archived) QA Specialist I

This position supports quality compliance systems and objectives within the Eagle Grove, IA site. The candidate maintains a quality mindset and implements continuous improvement efforts and quality system initiatives to industry requirements. This position will interact with cross-functional groups such as Quality Control, Production, and Regulatory Affairs.

POSITION RESPONSIBILITIES:

• Ensure approved quality systems are established and maintained.
  • Quality and compliance oversight of manufacturing and warehouse activities.
  • Helps prepare organization for FDA and other compliance audits.
  • Educate employees on quality system requirements and compliance expectations. Mentor employees to achieve compliance goals.
  • Develops training modules, provides new employee, cGMP, refresher and general training.
  • Attend training to update personal skills and knowledge level.

• Proactively and continuously improves Zoetis’ internal processes and products with quality mindset.
• Report on FDA and regulatory compliance inspections. Assist with developing remediation efforts & response, when necessary.
• Perform internal compliance (surveillance & focused) and supplier quality audits. Develop and maintain audit plan and prioritize audit focus points, conduct reviews of technical documentation, identify risks, determine actions and prepare final report.
• Work with personnel to facilitate and implement corrective and preventive action plans.
• Maintains and/or monitors compliance tracking systems and archive records, e.g. document control, deviation reporting, calibration, records retention, records destruct, etc.
• Understands and follows Pharmaceutical GMP regulations.
• Coordinates and investigates customer complaints.
• Disposition of raw materials and/or finished goods based on technical record review (e.g., manufacturing batch records; packaging and labeling; test results; reprocessing instructions; regulatory status; deviations).
• Assist in the development or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, etc.
• Coordinate and/or prepare periodic product review reports and MCSR documentation.
• Work within Document Management and Learning Management Systems.
• Provide Regulatory Affairs compliance support and review on regulatory submissions, approvals, product labeling, registrations and other projects.
  • Interpret and communicate existing and/or new regulatory requirements (e.g., 21 CFR Part 226) as they relate to company products, processes and procedures.
  • Prepare and/or verify data accuracy of supporting documentation for compliance submissions.
• Performs technical reviews and approves validation documents(e.g., IQ/OQ/PQ protocols and records of execution), quality support reports, and GMP related project documentation.
• Provides compliance and regulatory guidance for existing process, new products and processes, design review, construction and installation, and implementation.
• Develops supporting compliance documentation.
• Uses creativity, innovation, teamwork and problem-solving skills to accomplish project tasks, meet budgetary requirements and timelines.
• Ability to develop and communicate technical information with internal and external customers including regular weekly/monthly reporting activities.
• Ability to provide Quality oversight on the manufacturing floor, including assessing deviations, incidents, and other compliance support.

EDUCATION AND EXPERIENCE:

Level I:

• BS degree in a scientific field is required.
• A minimum of 2 years related experience preferably in an FDA regulated industry.
• Requires approximately 10% domestic travel and occasional international travel.
• Must possess strong oral and written communication skills and the ability to work independently.
• Must have an understanding of GMP and global regulatory standards.

TECHNICAL SKILLS REQUIREMENTS:

• Strong interpersonal and communication skills; ability to communicate across all levels of the organization.
• May contact vendors and/or external customers for administrative and technical information.
• Excellent attention to detail and strong time management skills.
• PC literate with the following applications: MS Excel, Word, Power Point