Seeking a Senior Quality Control Specialist to support GMP compliance in Tech Ops. This role involves managing QC activities with contract partners, authoring quality records, reviewing analytical data, and supporting method validation, stability programs, and regulatory submissions.

Key Responsibilities:

• Oversee release testing and stability programs for drug substances and products
• Author and review quality records (deviations, CAPA, change controls)
• Review analytical data packages for GMP compliance and support regulatory submissions and method validation
• Manage QC metrics, reference standards, and stability programs
• Collaborate cross-functionally to ensure compliance and timely issue resolution

Qualifications:

• BS in Analytical Chemistry (8+ years of QC experience) or Advanced degree with relevant experience
• Expertise in method validation, drug substance testing, and stability studies
• Experience with HPLC and analytical equipment
• Strong background in contract lab oversight, data review, and compliance
• Detail-oriented with excellent problem-solving and communication skills