Quality Specialist

Axiota Animal Health is hiring a Quality Specialist for its trace mineral solution division. The role supports quality and regulatory compliance for a globally registered sterile injectable veterinary drug product, including document controls, change control, batch record review, investigations, and FDA submissions.

Responsibilities

• Oversees the document control process within the quality management system
• Prepares documents and revisions for review and editing
• Prepares key data for quality metrics and assessments. Assists with related reports, summaries, and evaluations
• Works with cross-functional teams to complete FDA submissions of marketing and technical material to the FDA electronic portal
• Conducts investigations of incoming complaints, defects, deviations, or OOS according to internal procedures
• Assists with Quality Agreement Contract drafting and review process
• Supports quality risk assessments and external audits
• Works with external business partners to ensure compliance with internal standards and external regulatory requirements
• Supports other GXP functions as required

Preferred

• experience in the Animal Health industry preferred
• Comprehensive knowledge of global cGMP regulatory requirements for veterinary medicine and sterile injectable manufacturing processes
• Demonstrated ability to work in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of strategic goals
• Background in continuous improvement and implementation of quality metrics
• Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings
• Animal Health Industry Experience
• Global cGMP Regulations
• Veterinary Medicine
• Sterile Injectable Manufacturing
• Continuous Improvement
• Quality Metrics Implementation
• Strategic Goal Execution
• Multidisciplinary Collaboration
• Facilitation
• Interpersonal Skills
• Communication Skills

Benefits

• Bonus
• Medical, dental, and vision benefits
• Life insurance
• 401K retirement plan with match
• FSA
• HSA
• EAP
• Short-term and long-term disability
• Paid time off
• Paid holidays
• Remote work

Company

• Cattle health products for beef and dairy production
• Wamego, Kansas, USA
• https://axiota.com/
• Founded in 2020
• 51-200 employees

Qualifications

• Minimum of 2 years of pharmaceutical industry experience, with a minimum of 1 year in a Quality or regulatory role
• Bachelor's degree or higher in Life Sciences, Chemistry, Engineering, or a related field
• Bring contagious positive enthusiasm and an agile, proactive mindset to Quality and cGMP compliance
• Capable of partnering to assure suitability and cGMP compliance of the Supplier Quality program
• Have excellent communication and presentation skills and be able to articulate complex information to stakeholders and partners that utilize the Supplier Quality systems, including regulators and customers
• Experience with MS Office software suite
• Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills
• This position is not eligible for visa sponsorship
• Experience in the Animal Health industry preferred
• Comprehensive knowledge of global cGMP regulatory requirements for veterinary medicine and sterile injectable manufacturing processes
• Demonstrated ability to work in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of strategic goals
• Background in continuous improvement and implementation of quality metrics
• Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings

Required skills

• Continuous Improvement, Microsoft Office, Pharmaceutical Industry, Quality Assurance, Quality Metrics, Regulatory Affairs, Sterile Injectable Manufacturing, Supplier Quality, Veterinary Medicine, cGMP

Preferred skills

• experience in the Animal Health industry preferred

Experience

• 2+ years