QA Specialist at Amgen
Holly Springs, North Carolina, USA -
Full Time


Start Date

Immediate

Expiry Date

13 Sep, 25

Salary

129509.0

Posted On

15 Jun, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Decision Making, Communication Skills, Materials Management, Completion, Manufacturing Processes, Raw Materials

Industry

Pharmaceuticals

Description

BASIC QUALIFICATIONS:

  • High school diploma / GED and 10 years of Quality or Operations experience OR
  • Associate’s degree and 8 years of Quality or Operations experience OR
  • Bachelor’s degree and 4 years of Quality or Operations experience OR
  • Master’s degree and 2 years of Quality or Operations experience OR
  • Doctorate degree

PREFERRED QUALIFICATIONS:

  • Educational background in a science field
  • Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
  • Ability to complete tasks autonomously, problem solve and provide updates to senior management, and identifying potential issues
  • Knowledge of operations business processes, manufacturing processes and/or materials management
  • Demonstrated ability in problem solving
  • Experience working with dynamic cross-functional teams and demonstrated abilities in decision making
  • Strong organizational skills, including ability to follow assignments through to completion
  • Proficiency with Document Control, Change Controls, Exceptions Management
  • Previous disposition experience supporting raw materials and/or product
Responsibilities

Let’s do this! Let’s change the world!
In this vital role the specialist will leverage industry, technical, and quality systems knowledge to perform a comprehensive review of product manufacturing elements and execute a quality-critical disposition decision ensuring that batches are appropriately controlled.

The disposition specialist will lead and coordinate timely release of raw material product batches from assigned plants to ensure uninterrupted patient supply. The staff member will regularly present disposition status and metrics in a cross-functional leadership setting and proactively escalate supply interrupters. The individual will support waste reduction and patient supply at the site through leadership of and/or participation in continuous improvement initiatives.

  • Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.
  • Execute the Raw Material and Product disposition process as required per standard operating procedure.
  • Compilation and presentation of disposition metrics and status
  • Provide change control record quality assessments ensuring adherence to procedural requirements and regulatory expectations.
  • Support of internal audits
  • Direct interaction with regulatory agencies during on-site inspections
  • Provides quality expertise and guidance to operational staff and within cross functional
Loading...