QA Specialist III

The QA Specialist III/IV will provide QA support for Quality Operations in a fast-paced pharmaceutical environment. The position requires diverse skill sets and will provide the opportunity to challenge an individual's abilities to carry out the assigned responsibilities.

Requirements

• Perform batch record review and product disposition in support of clinical trials, registration, validation, and commercial product distribution
• Evaluate compliance of completed manufacturing records from CMO as necessary to ensure accuracy and completeness
• Collaborate with CMC to conduct compound/product specific risk assessments
• Review development, and validation protocols and reports
• Participate in ensuring compliance with quality systems, internal SOPs, deviations, OOS, product complaints, CAPAs, change controls-related processes and regulatory requirements
• Support QA CMO oversight activities to ensure required quality standards are maintained
• Support the reporting of Quality metrics on a monthly, and quarterly basis
• Support various quality risk management frameworks
• Support the Annual Product Quality Report preparation
• Support cGMP compliance audits of internal and GMP suppliers' quality systems
• Liaise with Regulatory Affairs on any manufacturing process changes that may impact regulatory filings
• Perform other related duties as assigned from time to time-based on company needs

Benefits

• 401(k) plan with generous employer match
• 12 weeks of paid parental leave
• Up to 12 weeks of living organ and bone marrow leave
• Equity incentive plans
• Health plans (medical, prescription drug, dental, and vision)
• Life insurance and disability
• Flexible time off
• Annual Winter Holiday shut down
• At least 11 paid holidays