Quality Assurance Specialist II, CMO

Role Summary

The QA Specialist II is responsible for overseeing and supporting external manufacturing operations of our global CMO partners. This is an individual contributor role that provides mid-level QA oversight of CMO operations in accordance with business agreements and international regulatory and industry standards. The role also provides mid-level administrative support and basic peer-to-peer guidance to junior team members within the internal quality department, along with administrative tasks and projects for management and quality personnel.

Responsibilities

• Partner closely with External Manufacturing, Supply Chain and Regulatory Affairs teams to ensure consistent and collaborative communication with external manufacturing partners
• Provide a single point of contact for QA technical support to internal teams and external manufacturing partners
• Effectively communicate issues, risks, and proposed solutions within the organization
• Assist with, conduct and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation
• Provide communication, support, and guidance to manufacturing partners and within the QA CMO team
• Facilitate implementation of policies and procedures for CMO compliance, including development of quality agreements; manage quality business processes and product disposition in line with strategy
• Perform batch record review and lot disposition activities as required
• Support internal and external audits as needed
• Create and revise standard operating procedures as needed
• Coach and mentor junior team members on a peer-to-peer level
• Other duties as assigned

Qualifications

• Minimum of BS/BA in a scientific discipline
• 5+ years of related industry experience with at least 3 years in quality assurance, quality control and compliance
• Proven track record on investigations, deviations, change controls, product quality complaints, and supplier qualification
• Strong organizational skills and ability to follow assignments through to completion
• Knowledge of relevant regulations and guidance documents
• Strong decision-making capability and ability to think strategically with global impact in mind
• Excellent verbal and written communication skills
• Detail-oriented with strong problem-solving and decision-making abilities
• Ability to work autonomously and meet deadlines
• Proficient in Microsoft Office (Outlook, Word, Excel)