The Senior Specialist, Quality Assurance is accountable for ensuring compliance with GMPs through documentation review, audits, and collaboration with cross-functional teams
Job Summary
The Senior Specialist, Quality Assurance is accountable for ensuring compliance with GMPs through documentation review, audits, and collaboration with cross-functional teams.
This role offers a hybrid work model requiring a minimum of 60% onsite support at production facilities and involves participation in regulatory inspections and continuous improvement initiatives.
The position provides a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, and vacation, with eligibility for annual bonus and long-term incentives.
Matching Summary
The Senior Specialist, Quality Assurance is accountable for ensuring compliance with GMPs through documentation review, audits, and collaboration with cross-functional teams.
Salary
Base: $106,200.00 - $167,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation
Skills & Requirements
Must-have
GMP documentation review and approval
Quality audits and inspections
Clinical supply manufacturing compliance
Root cause analysis and CAPA
Cross-functional team collaboration
Hybrid work model with onsite presence
Nice-to-have
Sterile dosage drug product experience
Quality risk management
Process improvements
Conflict resolution skills
Technical writing abilities
Adaptability to shift changes
Key Requirements
B.S. in Science or Engineering
5 years pharmaceutical industry experience
Knowledge of cGMP and EU regulations
Ability to work 1st and 2nd shifts
Experience with quality audits and regulatory inspections