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 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.
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
Perform routine audits
Root cause analysis techniques
Adhere to cGMPs and SOPs
On-site support of production facility
Nice-to-have
Collaborative working relationships
Continuous improvement initiatives
Flexibility and awareness of production
Build collaborative working relationships
Key Requirements
5 years of experience in pharmaceutical industry
B.S. in Science or Engineering discipline
Understanding of cGMPs and Good Documentation Practices
Sterile dosage drug product manufacturing experience preferred