Quality Specialist - Cgmp Manufacturing - Weekend 1st Shift

ALACAM

Morrisville, NC, US
Not specified; not specified; competitive salary +...
On-site (100% onsite, weekend 1st shift: friday - monday)
Bachelor's degree in chemistry or biology
3+ years of gmp experience
Review complex documents and protocols
Alcami is seeking a Quality Specialist for their cGMP Manufacturing team in Morrisville, NC, to provide quality and compliance support during the weekend shift. The ideal candidate will have relevant experience, strong knowledge of regulatory requirements, and the ability to develop quality documents and provide training

Job Summary

  • The Quality Specialist will provide site quality support in a fast-paced environment ensuring compliance with regulatory requirements.
  • Responsibilities include reviewing complex documents, supporting audits, developing SOPs, and providing training on quality topics.
  • Alcami offers a competitive salary, comprehensive benefits package including medical and 401(k) match, and opportunities for professional growth.

Matching Summary

Match Score: 85

Alcami is seeking a Quality Specialist for their cGMP Manufacturing team in Morrisville, NC, to provide quality and compliance support during the weekend shift. The ideal candidate will have relevant experience, strong knowledge of regulatory requirements, and the ability to develop quality documents and provide training.

Salary

Not specified; Not specified; Competitive salary and exceptional benefits package including medical, dental, vision, life, LTD, STD, 401(k) with match, and tuition reimbursement

Skills & Requirements

Must-have

  • Bachelor's degree in Chemistry or Biology
  • 3+ years of GMP experience
  • Review complex documents and protocols
  • Support audits and inspections
  • Maintain quality databases

Nice-to-have

  • Experience in environmental monitoring
  • Knowledge of critical utilities for sterile operations
  • Ability to mentor others
  • Strong negotiation skills
  • Technical consultant capabilities

Key Requirements

  • Bachelor's degree required
  • 3+ years related experience
  • Relevant GMP experience required
  • US work authorization not specified

Work Rights

Not specified

Tailored Resume

Cover Letter