Associate Specialist, Quality Assurance

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.

Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do.

This role will primarily support the Services IPT (Integrated Process Team) at the Elkhorn site. This team member will provide guidance from a quality compliance perspective, leveraging knowledge of local and global Animal Health standards, USDA regulations, and general cGMP principles. This team member will also be expected to regularly spend time within the department to learn processes, evaluate compliance, and build relationships of trust within the Services IPT and other departments.

This position will serve as a Quality representative in Reliance quality systems, Deviation Management, and Change Controls for the Services IPT group. This role will review process deviations, change controls, and other qualification documents for QA to ensure regulatory requirements are being followed. Additionally, this team member will assist with release activities for FPP (Final Packaged Product) and support documentation review activities, batch issuance, and other documentation administration tasks.

Additionally, this role will occasionally be assigned short-term tasks and projects with varying degrees of urgency and difficulty; therefore, organization, critical thinking, and creativity are necessary attributes for success.

A successful candidate will navigate the various perspectives of Planning, QA, Maintenance, Engineering, and Production utilizing established Leadership Behaviors and principles of Inclusion, while holding Safety and Quality as primary values.

Additional Duties & Responsibilities:

• Perform and assist other QA team members with internal Self-Inspections (site walkthroughs and audit-readiness reviews).
• Serve as the primary back-up to a number of critical site QA roles and functions.
• Key participant in Quality Compliance Inspections from external regulatory and off-site entities.
• Support visual management systems (such as the QA T-Card tracker) and batch release administrative workflows.
• Other tasks as assigned by the QA Manager and Quality Senior Leaders.

Planning Auditing Aviation Vaccines Chemistry Leadership Management Innovation Creativity Compassion SAP S/4HANA Microbiology Investigation Collaboration Animal Health Change Control Pharmaceuticals Problem Solving Decision Making Medical Devices Safety Assurance Telephone Skills Quality Auditing Critical Thinking Technical Writing Biopharmaceuticals Project Management Lean Manufacturing Quality Management Aseptic Processing Root Cause Analysis Contingent Workforce Deviation Management Regulatory Requirements Quality Management Systems Verbal Communication Skills Internet Protocol Telephony Code Of Federal Regulations Good Manufacturing Practices Continuous Improvement Process Enterprise Application Software, * High School Diploma with at least five (5) years of relevant industry experience OR

• Associate’s Degree with at least three (3) years of relevant industry experience OR
• Bachelor’s Degree (degree in the sciences preferred), * Minimum of two (2) years of experience working in a regulated industry (e.g., Pharmaceuticals, Biologics, Medical Devices, or Aviation/Military).
• Strong written and verbal communication skills with a demonstrated ability to collaborate cross-functionally.
• Foundational QA knowledge of deviation management and change control processes.
• Hands-on experience navigating quality management systems, including participating in investigations and risk assessments.

Preferred Experience and Skills:

• Familiarity and/or direct experience with vaccine manufacturing and/or biological testing.
• Familiarity with USDA regulations (9 CFR) and regulatory inspections.
• Prior experience utilizing standard enterprise systems such as Reliance, SAP (S/4HANA), and MEDS.
• Knowledge of lean manufacturing or continuous improvement frameworks such as: Standardized Work and On-Point Problem Solving (OPPS).
• Strong Microbiology, Biology, Chemistry, or Engineering background.
• Basic Project Management experience., Analytical Problem Solving, Aseptic Filling, cGMP Compliance, Complaint Management, Decision Making, Deviation Management, Good Manufacturing Practices (GMP), Quality Auditing, Quality Management Standards, Quality Management Systems (QMS), Quality Standards, Quality Support, Root Cause Analysis (RCA), Technical Writing, Training and Development, Planning Auditing Aviation Vaccines Chemistry Leadership Management Innovation Creativity Compassion SAP S/4HANA Microbiology Investigation Collaboration Animal Health Change Control Pharmaceuticals Problem Solving Decision Making Medical Devices Safety Assurance Telephone Skills Quality Auditing Critical Thinking Technical Writing Biopharmaceuticals Project Management Lean Manufacturing Quality Management Aseptic Processing Root Cause Analysis Contingent Workforce Deviation Management Regulatory Requirements Quality Management Systems Verbal Communication Skills Internet Protocol Telephony Code Of Federal Regulations Good Manufacturing Practices Continuous Improvement Process

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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The salary range for this role is $71,900.00 - $113,200.00

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.