Provide Quality Assurance (QA) support to clinical phase API Manufacturing and Testing

·       Provide Quality Assurance (QA) support to clinical phase API Manufacturing and Testing

·       Oversight of Quality Systems and Document Control

·       Work with the cross-discipline groups to improve the effectiveness of Quality Systems

·       Serve as key quality SME on project teams

·       Lead or support investigations to close Quality Events, Deviations, Document in Impact Investigation, Root Cause Analysis, and CAPAs

·       Review and approve cGMP Documentation: SOPs, Production batch records, testing records, logs, labels, protocols, and reports, to ensure compliance for cGMP activities

·       Train production and laboratory personnel on cGMP compliances

·       Review and approve activities for cGMP facility and equipment qualification and validation

·       Conduct internal quality audits, track progress, and trend results

·       Coordinate and facilitate quality auditing and inspection from customers and authorities

Other activities as directed by site leadership

Minimum BS in a scientific discipline or equivalent with a minimum of 5-7 years' experience in an cGMP regulated industry.

·       Bachelor’s or Masters degree in chemistry highly preferred

·       Must have experience working in a cGMP environment in the API pharmaceutical industry and have strong knowledge and thorough understanding of cGMP regulations and guidelinees

·       Small molecule API experience highly preferred

·       Experiences with analytical instrumentations a plus

·       Experience with Quality Management Systems

·       Effective written and verbal communication skills

·       Self-motivated with “can do” mentality

Superior attention to detail, strong organizational skills and the ability to