The Senior Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs
Job Summary
The Senior Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs.
They independently perform routine audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure compliance with SOPs, GMPs and other applicable worldwide regulations and company procedures.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable, and benefits including medical, dental, vision, retirement plans, paid holidays, vacation, and sick days.
Matching Summary
The Senior Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs.
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, sick days
Skills & Requirements
Must-have
GMP documentation review and approval
Routine GMP audits
Quality assurance systems
Clinical supply manufacturing compliance
cGMP and SOP adherence
Audit and inspection readiness
Shift flexibility first and second shift
Nice-to-have
Sterile dosage drug product experience
Cross-functional team collaboration
Root cause analysis and CAPA
Quality risk management
Strong interpersonal and communication skills
Continuous improvement initiatives
Hybrid work model
Key Requirements
B.S. in Science or Engineering
5 years pharmaceutical industry experience
Understanding of cGMP and drug regulations
Experience with quality audits and EU regulatory inspections