Responsibilities:
- Minimum 7 years of experience in quality assurance in the biotech or pharmaceutical industry
- Small Molecules, Solid Oral Dosage experience.
- Develop, implement, and maintain quality assurance programs, policies, and procedures in compliance with regulatory standards (e.g., FDA, EMA, ICH).
- Perform regular quality audits of processes, equipment, and documentation to ensure adherence to established protocols.
- Review and approve batch records, standard operating procedures (SOPs), and other quality-related documents.
- Collaborate with production, research, and development teams to address quality issues and implement corrective actions.
- Stability and analytical testing experience.
- Experience with quality management systems (QMS) and document control.
Contract:
- Start Date: ASAP
- Length: 6 months
- Hours: 40 hours per week
- Remote
- W2
