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Associate Specialist, Quality Assurance

Job in Northern, Floyd County, Kentucky, USA
Listing for: MSD Malaysia
Full Time position
Listed on 2026-09-16
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
Salary/Wage Range or Industry Benchmark: 71900 - 113200 USD Yearly USD 71900.00 113200.00 YEAR
Job Description & How to Apply Below
## Associate Specialist, Quality Assurance Apply:
Not Applicable:
USA
- Nebraska
- Elkhorn:
Full time:
Posted Today:
End Date:
September 24, 2026 (13 days left to apply):
R416565
** Job Description
** 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.
** Required

Education & Experience:

*** 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)
** Required

Experience and Skills:

*** 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/4

HANA), 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.#MSJR
*
* Required Skills:

** 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
** Preferred

Skills:

** Current Employees apply HERE Current Contingent Workers apply HERE
** US and Puerto Rico Residents Only:
** Our company is…
Position Requirements
10+ Years work experience
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