International Seed Management Specialist

MSD • De Soto, KS

3d • Hybrid

About The Position

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Position Description Subject Matter Expert (SME) for Seeds in the US region. Accountable for support and advice for US biological groups (Research & Development (R&D), Our company's Manufacturing Division, Regulatory Affairs (RA), Biotechnology Solutions (BTS) for production and testing of Seed materials; provide technical direction to ensure compliant production Seeds are produced in US region (including Seeds for EU/global). Coordinates Master Seed testing in the US region; includes advice on raw materials, volumes, containers, labels, storage, and testing specification for all Master Seeds produced in US region, consulting with SMEs from Biotechnology Solutions, Research & Development, Regulatory Affairs, and Quality. Promotes harmonized approach with International Seed Management for all US Seeds according to International Seed Management policies/guidelines. Assists divisional auditing teams during audits on adherence to International Seed Management policies on US sites as appropriate. Supports our company's US Manufacturing Division and Quality Assurance groups regarding Seed Management and remaining in compliance with USDA requirements and our company's Animal Health global policies. This position can be located in Elkhorn, NE, De Soto, KS or Millsboro, DE.

Requirements

• Bachelor’s Degree in a Relevant Biological Area (Bacteriology, Biochemistry, Biology, Genetics, Immunology, Microbiology, Virology)
• 3+ years USDA industry experience (Animal Health experience preferred)
• Project management and product investigation experience
• Expanded knowledge in at least one biological area, experience in other biological areas
• Experience in participating/leading cross-functional teams
• Proficient in technical writing and use of Microsoft programs (Excel, PowerPoint, Word)
• Excellent communication, interpersonal, and organizational skills
• Aseptic Manufacturing
• Aseptic Manufacturing
• Audits Compliance
• Bacteriology
• Biological Assessments
• Biotechnology
• Corrective and Preventive Action (CAPA)
• Detail-Oriented
• Documentation Review
• Driving Continuous Improvement
• Global Manufacturing
• GMP Compliance
• Good Manufacturing Practices (GMP)
• Healthcare Innovation
• Immunoassays
• Immunochemistry
• Immunology
• Microbiology
• Quality Assurance Tools
• Quality Auditing
• Quality Management Systems (QMS)
• Quality Standards
• Root Cause Analysis (RCA)
• SAP Project System (PS)
• Supplier Quality Management

Nice To Haves

• Experience in biological testing and/or biological production processes
• Seed management experience desired, but not required
• Knowledge of USDA regulations and requirements for licensure and extraneous agents testing of Seeds
• Preparation of business risk assessments
• Knowledge of quality management systems (Good Laboratory Practice (GLP)/ Good Manufacturing Practice (GMP)/ International Organization for Standardization (ISO)
• Experience with the Systems Applications and Products (SAP) system

Responsibilities

• Subject Matter Expert (SME) for Seeds in the US region.
• Accountable for support and advice for US biological groups (Research & Development (R&D), Our company's Manufacturing Division, Regulatory Affairs (RA), Biotechnology Solutions (BTS) for production and testing of Seed materials
• Provide technical direction to ensure compliant production Seeds are produced in US region (including Seeds for EU/global).
• Coordinates Master Seed testing in the US region; includes advice on raw materials, volumes, containers, labels, storage, and testing specification for all Master Seeds produced in US region, consulting with SMEs from Biotechnology Solutions, Research & Development, Regulatory Affairs, and Quality.
• Promotes harmonized approach with International Seed Management for all US Seeds according to International Seed Management policies/guidelines.
• Assists divisional auditing teams during audits on adherence to International Seed Management policies on US sites as appropriate.
• Supports our company's US Manufacturing Division and Quality Assurance groups regarding Seed Management and remaining in compliance with USDA requirements and our company's Animal Health global policies.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees