Job Description
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.**
Position Qualifications
Education:
Bachelor’s Degree in a Relevant Biological Area (Bacteriology, Biochemistry, Biology, Genetics, Immunology, Microbiology, Virology)
Qualifications and Skills:
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
Preferred Qualifications and Skills:
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
Required 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 {+ 1 more}Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is
$85,600.00 - $134,800.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
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.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
01/15/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.