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.
The position will initially be assigned to 1st shift (e.g., 7:00 AM–3:00 PM) initially for training purposes, and will be expected to transition to 2nd shift (e.g., 3:00 PM–11:00 PM) once training is complete.
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
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: Comprehensive package including medical, dental, vision, retirement, paid holidays, vacation, sick days
Skills & Requirements
Must-have
GMP documentation review and approval
Clinical drug product manufacture
Root cause analysis techniques
Regulatory agency inspections preparation
Adhere to cGMPs and SOPs
Nice-to-have
Collaborative working relationships
Continuous improvement initiatives
Flexibility and awareness of production
Attention to detail
Key Requirements
5 years of experience
B.S. in Science or Engineering
Understanding of cGMPs and EU regulations
Experience in quality control or assurance
Sterile dosage drug product manufacturing experience