Quality Management Rep

Takeda

Indianapolis, IN, US
Base: $63,080.00 - $86,735.00; bonus/equity: short...
Cgmp regulatory compliance knowledge
Plasma center operations experience
Sop development and monitoring skills
The role ensures source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP) and company regulations

Job Summary

  • The role ensures source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP) and company regulations.
  • Employees are authorized and responsible to cease operations or stop shipments if donor or product safety is compromised.
  • The position offers a comprehensive benefits program including medical, dental, vision insurance, 401(k) match, and paid time off.

Matching Summary

The role ensures source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP) and company regulations.

Salary

Base: $63,080.00 - $86,735.00; Bonus/Equity: Short-term and/or long-term incentives eligible; Benefits: Medical, dental, vision, 401(k), paid vacation, sick time

Skills & Requirements

Must-have

  • cGMP regulatory compliance knowledge
  • plasma center operations experience
  • SOP development and monitoring skills
  • FDA regulated environment understanding
  • audit preparation and execution

Nice-to-have

  • strong problem-solving abilities
  • effective coaching and counseling skills
  • continuous improvement methodologies
  • teamwork and collaboration focus
  • data analysis proficiency

Key Requirements

  • High School Diploma required
  • Minimum one-year relevant work experience
  • Experience in FDA-regulated environment preferred
  • Plasma collection industry experience strongly preferred

Work Rights

Not specified

Tailored Resume

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