Qa Senior Specialist

leHACK

Base: $106,200.00 - $167,200.00; bonus/equity: eli...
Hybrid (3 days on-site, 1 day remote)
Cgmp compliance and regulatory requirements
Quality systems management
Gmp documentation review
The Senior Quality Specialist at leHACK is responsible for ensuring compliance with cGMPs and regulatory standards through quality oversight and auditing activities in a manufacturing environment. The ideal candidate should possess a background in quality assurance and experience with GMP documentation, alongside leadership and communication skills

Job Summary

  • The Senior Quality Specialist ensures site-wide compliance with cGMPs and regulatory requirements through robust quality systems and proactive auditing.
  • This role provides quality oversight for manufacturing operations, managing critical quality systems, conducting GMP walkthroughs, and supporting inspections.
  • The position partners closely with Operations and other functions to identify and implement continuous improvement initiatives and support investigations.

Matching Summary

Match Score: 85

The Senior Quality Specialist at leHACK is responsible for ensuring compliance with cGMPs and regulatory standards through quality oversight and auditing activities in a manufacturing environment. The ideal candidate should possess a background in quality assurance and experience with GMP documentation, alongside leadership and communication skills.

Salary

Base: $106,200.00 - $167,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, retirement, holidays, vacation, sick days

Skills & Requirements

Must-have

  • cGMP compliance and regulatory requirements
  • Quality systems management
  • GMP documentation review
  • Biologics regulatory requirements

Nice-to-have

  • Leadership skills and communication
  • Continuous improvement initiatives
  • Risk management

Key Requirements

  • Associate degree with 5 years experience
  • Bachelor's degree with 3 years experience
  • Familiarity with GMP documentation review
  • Leadership skills
  • Good oral and written communication

Work Rights

Not specified

Tailored Resume

Cover Letter