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 the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company procedures.
• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable, and the company offers a comprehensive package of benefits including medical, dental, vision healthcare, retirement benefits, paid holidays, vacation, and sick days.

Matching Summary

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

Key Requirements

• B.S. in Science or Engineering
• 5 years pharmaceutical industry experience
• Understanding of cGMP and drug regulations
• Experience in quality control or assurance
• Ability to work 1st and 2nd shifts
• Willingness to work hybrid schedule
• Experience with EU regulatory inspections

Work Rights