Sr. Quality Assurance Specialist

ALCAMI

Morrisville, NC, US
Not specified; competitive salary mentioned; benef...
**
10+ years gmp related experience
Aseptic parenteral manufacturing knowledge
Grade c gowning proficiency
** Alcami is seeking a Senior Quality Assurance Specialist for their Morrisville, NC location, responsible for ensuring compliance with regulatory requirements in a fast-paced environment. The ideal candidate should have extensive GMP experience and a strong background in quality assurance, alongside a collaborative mindset to mentor team members. **

Job Summary

  • The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by ensuring quality and compliance with regulatory requirements.
  • This role involves performing visual inspections of parenteral products, conducting internal audits, and supporting client and regulatory inspections.
  • Alcami offers a competitive salary, exceptional benefits package including medical and dental coverage, and opportunities for professional growth.

Matching Summary

Match Score: 75

** Alcami is seeking a Senior Quality Assurance Specialist for their Morrisville, NC location, responsible for ensuring compliance with regulatory requirements in a fast-paced environment. The ideal candidate should have extensive GMP experience and a strong background in quality assurance, alongside a collaborative mindset to mentor team members. **

Salary

Not specified; Competitive salary mentioned; Benefits include medical, dental, vision, 401(k) with match

Skills & Requirements

Must-have

  • 10+ years GMP related experience
  • Aseptic parenteral manufacturing knowledge
  • Grade C gowning proficiency
  • GMP and Annex 1 experience
  • 20/20 corrected vision for inspection

Nice-to-have

  • Mentoring Operations personnel
  • Process improvement initiatives
  • Client consultation skills
  • SOP development assistance

Key Requirements

  • Bachelor's degree in Chemistry or Biology
  • Master's degree in related field as alternative
  • Minimum five years of related work experience
  • US citizenship not explicitly required but location is US-NC

Work Rights

Not specified

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