Alcami Corporation · 1 day ago
Sr. Quality Assurance Specialist - GMP , RA
Durham, NC
Full-time
Hybrid
Senior Level
5+ years expAlcami Corporation delivers reliable solutions that unlock the potential of transformative medicines. The Senior Quality Assurance Specialist is responsible for ensuring quality and compliance with regulatory requirements, conducting audits, and providing guidance on GMP compliance.
Pharmaceuticals
Responsibilities
Provide regulatory expertise and strategy for clients on their products and services
Performs quality/regulatory review and approval of documents, data, protocols, and/or reports
Performs negotiations for new quality agreements
Represents regulatory in intracompany meetings and client meetings
Maintains licenses and current registrations
Supports internal quality audits and/or inspections
Supports client audits and inspections, and regulatory inspections and responses
Maintains regulatory databases
Assists with implementation and supports quality systems, including but not limited to, operations support, training, vendor management, and overall regulatory inspectional readiness
Assists with quality improvement initiatives as needed
Assists with development of SOPs or other quality documents
Maintains accurate files and records
Serves as an effective member of the Quality Assurance team and may serve as a mentor to others in area of expertise
Complies with company polices and SOPs
Ensures timely completion and compliance with cGMP and all other relevant company training requirements
Other duties as assigned
Qualification
Required
Bachelor's degree in Chemistry, Biology, or related field with 10+ years of GMP related experience, or Master's degree in related field
Minimum five years of related work experience
Aseptic parenteral manufacturing or oral solid dosage form manufacturing
GMP and Annex 1 experience
Good writing and communication skills
Proficient in regulatory submissions (IND, ANDA, NDA, BLA, NADA)
Company
Alcami Corporation
Alcami is a US-based contract development and manufacturing organization headquartered in NC with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase