Key skills
Change ManagementCommunication
About this role
Role Overview
- Perform GMP documentation review and approval for internal or outsourced manufacturing of clinical supplies including batch records, deviation and/or out-of-specification approval, change management approval, etc.
- Support the Quality Program Lead on inter-departmental and cross-functional teams, ensuring communication of accurate information and providing quality guidance and/or deliverables.
- Accountable for all assigned projects and communication of status to the Management team.
- Identify need for and/or develop SOPs to ensure practices are accurately reflected.
- Adhere to cGMPs and SOPs
Requirements
- B.S. in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology)
- 5 years of experience in the pharmaceutical or related industry
- Understanding of current Good Manufacturing Practices (cGMPs) and Good Documentation Practices and related drug regulation requirements, including European Union.
- Experience in one or more functional areas such as quality control, quality assurance, analytical laboratories, manufacturing, production support area, clinical development
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days