Alcami Corporation · 2 months ago
Sr. Quality Assurance Specialist - 2nd shift
US-NC-Morrisville
Full-time
Onsite
Senior Level
5+ years expAlcami Corporation is a trusted partner in delivering reliable solutions for transformative medicines. The Senior Quality Assurance Specialist is responsible for ensuring quality and compliance with regulatory requirements, conducting audits, and maintaining quality databases while mentoring team members in GMP compliance.
Pharmaceuticals
Responsibilities
Performs quality review and approval of documents, data, protocols, and/or reports
Performs GMP document creation and issuance (batch records, logbooks, forms, etc.)
Performs visual inspection of parenteral product (requires qualification)
Performs internal quality audits and/or inspections
Supports client audits and inspections, and regulatory inspections
Maintains quality databases
Assists with implementation and supports quality systems, including but not limited to, operations support, batch review and approval, training, vendor management, and overall regulatory inspectional readiness
Assists with quality improvement initiatives as needed
Consults with clients on production and documentation
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
Preferred
Aseptic parenteral manufacturing
Grade C gowning
GMP and Annex 1 experience
20/20 corrected vision for Visual Inspector qualification
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