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. The role provides mid-level QA oversight of CMO operations in accordance with business agreements and international regulatory and industry standards, with additional administrative support and peer-to-peer guidance to junior team members within the internal quality department.

Responsibilities

• Partner closely with External Manufacturing, Supply Chain and Regulatory Affairs teams to ensure consistent and collaborative communication to external manufacturing partners
• Work cross functionally to provide a single point of contact for QA technical support to internal team 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
• Facilitates implementation of policies and procedures for CMO compliance, including development of quality agreements; quality business processes and product disposition in accordance with team-derived 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

• BS/BA in a scientific discipline
• 5+ years of related industry experience with a minimum of 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 considerations
• Excellent verbal and written communication skills
• Detail-oriented with problem-solving and solid decision-making abilities
• Experience working autonomously with proven ability to meet deadlines
• Proficient in Microsoft Office (Outlook, Word, Excel)