Qa Senior Specialist

Mayoly

Base: $106,200.00 - $167,200.00; bonus/equity: ann...
Hybrid (3 days on-site, 1 day remote)
Cgmp compliance
Regulatory requirements
Quality systems management
Mayoly is seeking a Senior Quality Specialist to ensure compliance with cGMPs and regulatory requirements through quality systems and auditing. This hybrid role involves managing critical quality systems, conducting GMP inspections, and collaborating with Operations for continuous improvement initiatives

Job Summary

  • This role provides quality oversight for manufacturing operations, with primary responsibility for managing and executing critical quality systems.
  • The Senior Quality Specialist performs detailed review and approval of batch records, SOPs, and quality documentation to ensure accuracy, completeness, and Right First Time (RFT) execution.
  • The salary range for this role is $106,200.00 - $167,200.00 and the successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Matching Summary

Match Score: 85

Mayoly is seeking a Senior Quality Specialist to ensure compliance with cGMPs and regulatory requirements through quality systems and auditing. This hybrid role involves managing critical quality systems, conducting GMP inspections, and collaborating with Operations for 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
  • change control management

Nice-to-have

  • continuous improvement initiatives
  • leadership skills
  • 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
  • Understanding of cGMPs and regulatory requirements
  • Valid Driving License

Work Rights

Not specified

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