Qa Senior Specialist

539

Base: $106,200.00 - $167,200.00; bonus/equity: ann...
Hybrid (3 days onsite, 1 day remote)
Cgmp compliance
Regulatory requirements
Quality systems management
The Senior Quality Specialist position at 539 seeks a leader to ensure compliance with cGMP regulations and oversee quality systems in manufacturing operations. The role involves managing quality documentation, conducting GMP inspections, and collaborating with various departments to implement continuous improvement initiatives

Job Summary

  • The Senior Quality Specialist ensures site-wide compliance with cGMPs and regulatory requirements through robust quality systems and proactive auditing activities.
  • This role provides quality oversight for manufacturing operations, with primary responsibility for managing and executing critical quality systems.
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable, and a comprehensive package of benefits including medical, dental, vision, and retirement benefits.

Matching Summary

Match Score: 85

The Senior Quality Specialist position at 539 seeks a leader to ensure compliance with cGMP regulations and oversee quality systems in manufacturing operations. The role involves managing quality documentation, conducting GMP inspections, and collaborating with various departments to implement continuous improvement initiatives.

Salary

Base: $106,200.00 - $167,200.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Medical, dental, vision healthcare and other insurance benefits, retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days

Skills & Requirements

Must-have

  • cGMP compliance
  • regulatory requirements
  • quality systems management
  • batch record review
  • SOP review and approval
  • deviation management

Nice-to-have

  • continuous improvement initiatives
  • team-based environment
  • proactive auditing activities
  • risk management

Key Requirements

  • Associate degree with five years experience
  • Bachelor's degree with three years experience
  • Familiarity with GMP documentation review
  • Leadership skills
  • Good oral and written communication skills
  • Understanding of cGMPs and regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter