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Merck · 1 day ago

International Seed Management Specialist

USA - Nebraska - Omaha

Full-time

Hybrid

Mid Level

$86K/yr - $135K/yr

3+ years exp

Merck is a leading global healthcare company, and they are seeking an International Seed Management Specialist to serve as a Subject Matter Expert for Seeds in the US region. The role involves providing technical support and advice for various biological groups, coordinating Master Seed testing, and ensuring compliance with regulatory requirements.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

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

Qualification

USDA industry experienceBiological testingUSDA regulationsProject managementMicrosoft programsSeed managementTechnical writingDriving Continuous ImprovementQuality Assurance ToolsRoot Cause Analysis (RCA)Supplier Quality ManagementCommunicationInterpersonal skillsOrganizational skillsDetail-oriented

Required

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

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

Preferred

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