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. The position 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; The successful candidate will be eligible for annual bonus and long-term incentive, if applicable; We offer a comprehensive package of benefits.
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 healthcare and other insurance benefits, retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days
Skills & Requirements
Must-have
GMP documentation review and approval
Clinical supply programs
Regulatory agency inspections
Root cause analysis techniques
On-site support of production facility
Nice-to-have
Collaborative working relationships
Continuous improvement initiatives
Effective communications with stakeholders
Awareness of production quality problems
Key Requirements
5 years of experience in pharmaceutical industry
B.S. in Science or Engineering discipline
Sterile dosage drug product manufacturing experience