Job Description
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 disposition of any impacted product batches. Evaluate deviations and propos...
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 disposition of any impacted product batches. Evaluate deviations and propos...