Alcami Corporation · 6 hours ago
Sr. Compliance Specialist
Durham, NC
Full-time
Hybrid
Senior Level
5+ years expAlcami Corporation is dedicated to delivering reliable solutions for transformative medicines from discovery to commercialization. The Senior Compliance Specialist will ensure quality and compliance with regulatory requirements by performing audits, maintaining quality databases, and providing guidance to other compliance employees.
Pharmaceuticals
Responsibilities
Performs quality review and approval of documents, data, protocols, and/or reports
Performs internal and external quality audits and/or inspections
Serves as a Lead Inspector for external audits
Hosts client audits and inspections
Hosts regulatory inspections
Maintains quality databases
Assists with the implementation and supports quality systems, including but not limited to vendor management
Training, internal audit program, and overall regulatory inspectional readiness initiatives
Assists with quality improvement initiatives as needed
Consults with clients on all levels of regulatory issues
Assists with development of SOPs or other quality documents as needed
Maintains accurate files and records
Serves as an effective member of the Compliance 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 with 5+ years of related experience, or equivalent educational and work experience
Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise
Good written and oral communication skills
Good math skills
Good computer skills and knowledge of Microsoft Office products
Ability to be trained and to mentor
Ability to interact well with clients and regulatory agents
Ability to interact well with employees at all levels
Ability to negotiate
Ability to lead audits
Ability to act as a consultant
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