Base: $90,000 - $105,000 usd; bonus/equity: not sp...
On-site
Gmp investigation leadership
Root cause analysis methodologies
Capa development and oversight
Arrowhead Pharmaceuticals is seeking a GMP Investigation Lead within their Quality Control team in Verona, Wisconsin. The role focuses on managing and authoring investigations related to quality control deviations in a GMP environment, requiring strong analytical skills and a deep understanding of compliance standards
Job Summary
The role involves leading and managing deviations, OOS/OOT/Atypical laboratory investigations, and associated change control records within a GMP environment.
Candidates must demonstrate proficiency with various analytical instruments including HPLC, GC, LC-MS, and Endotoxin plate readers.
Arrowhead Pharmaceuticals is a commercial stage company focused on developing RNAi-based therapeutics for intractable diseases.
Matching Summary
Match Score: 85
Arrowhead Pharmaceuticals is seeking a GMP Investigation Lead within their Quality Control team in Verona, Wisconsin. The role focuses on managing and authoring investigations related to quality control deviations in a GMP environment, requiring strong analytical skills and a deep understanding of compliance standards.
Salary
Base: $90,000 - $105,000 USD; Bonus/Equity: Not specified; Benefits: Competitive salaries and excellent benefit package
Skills & Requirements
Must-have
GMP investigation leadership
Root cause analysis methodologies
CAPA development and oversight
cGMP and GDP knowledge
Laboratory instrumentation proficiency
Nice-to-have
Cross-functional collaboration skills
Regulatory inspection support experience
Veeva QMS system proficiency
Complex risk communication abilities
Continuous improvement mindset
Key Requirements
Minimum B.S. in Chemistry or related field
5+ years of work experience required
Experience in Pharmaceutical or oligonucleotide manufacturing preferred