[Hiring] Quality Specialist @b82a2d71-2767-476d-bd31-e910e2b3d9d3

Role Description

This role is within the Quality organization specific to our trace mineral solution division within the Axiota Animal Health family of products. The candidate chosen for this role will be accountable for quality and compliance responsibilities associated with a globally registered sterile injectable veterinary drug product. The candidate will provide document management controls, change control, batch record review, deviation and CAPA management, and will be responsible for electronic submissions of promotional and marketing material via the FDA electronic submission portal. The specialist’s role will be to work and collaborate with assigned CMOs, Vendors, and Distributors and will report to the Global Director of Quality and Regulatory for the Multimin Product Line. The position will be remote and may require occasional travel.

• 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.

Qualifications

• Minimum of 2 years of pharmaceutical industry experience, with a minimum of 1 year in a Quality or regulatory role; experience in the Animal Health industry preferred.
• 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.
• Currently live in or be willing to self-relocate to the Central or Eastern time zone.

Preferred Skills/Qualifications

• 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.

Benefits

• A nationally competitive base salary plus bonus and benefits packages.
• Medical, dental, vision, life insurance.
• 401K retirement plan with match.
• FSA, HSA, EAP.
• Short-term and long-term disability.
• Paid time off and paid holidays.

Company Description

Axiota Animal Health delivers best-in-class animal health products with proven modes of action that help manage risk and support cattle health, performance, and well-being across all stages of beef and dairy production. Axiota is the intersection of committed people, proven products, and sound science, assuring customers and consumers by preparing cattle to thrive.