Alcami Corporation · 10 hours ago
Quality Specialist - GMP
Wilmington, NC
Full-time
Onsite
Mid Level
3+ years expAlcami Corporation is a company that delivers reliable solutions for transformative medicines through trusted partnerships and industry expertise. The Quality Specialist will provide site quality support, ensuring compliance with regulatory requirements and performing a variety of quality-related activities such as document review, audit support, and quality training.
Pharmaceuticals
Responsibilities
Performs quality review and approval of complex documents, all types of data, protocols, and/or reports
Supports quality floor audits and/or floor inspections
Supports for client and regulatory agency audits and inspections
Provides quality evaluation and release of support materials, products, equipment and facilities as required
Maintains quality databases and may perform analysis and trending
Assists with quality improvement initiatives as needed
Develops quality SOPs or other quality documents and/or reports as needed
Provides consultation on complex quality and compliance topics in areas of expertise
Develops and provides training in quality and compliance topics in areas of expertise
Provides Quality oversite for the site specific Quality Management Systems including Investigations, Corrective Actions, Change control, etc
Effectively performs a variety of complex duties, on schedule, with accuracy and competency
Maintains accurate files and records
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 relevant field and 3+ years of related experience required, or Master's degree in relevant field and 1+ years of related experience
Relevant GMP experience required
Preferred
Experience in laboratory preferred
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