Target Salary Range: $101,500 – $135,300 per year (salary to be determined by education, experience, knowledge, skills and abilities of applicant, internal equity, and alignment with market data)

We are a contract development and manufacturing organization (CDMO) that provides CMC services to biotechnology and pharmaceutical companies, helping them develop and manufacture complex delivery-based drug formulations.

Responsibilities

• Maintain and revise QA related procedures, as needed.
• Maintain cGMP training systems and perform on-site team member training in Quality related matters.
• Ensure GxP support and oversight for relevant site functions and activities.
• Support QA team members with senior QA level knowledge, experience, guidance, coaching and mentoring.
• Perform QA batch record review and disposition of manufactured early phase clinical product batches.
• Provide final QA approval of investigations and dispo...