Sr. Quality Assurance Specialist - GMP , Regulatory Affairs
AlcamiDurham, North Carolina, United States
Posted January 7, 2026
Full Time
About the Company
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.
Job Description
The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities to ensure quality and compliance with applicable regulatory requirements and internal procedures.
Requirements
- Bachelor’s degree in Chemistry, Biology, or related field
- 10+ years of GMP related experience
- Good writing and communication skills
- Proficient in regulatory submissions (IND, ANDA, NDA, BLA, NADA)
