Alcami Corporation · 2 days ago
Quality Control Data Review Specialist - GMP , Chromatography
Wilmington, NC
Full-time
Hybrid
Entry, Mid Level
2+ years expAlcami Corporation delivers reliable solutions that unlock the potential of transformative medicines. The Quality Control Data Review Specialist is responsible for ensuring quality and compliance by reviewing documents and data, conducting audits, and maintaining quality databases while working within a fast-paced laboratory environment.
Pharmaceuticals
Responsibilities
Performs detailed review and approval of all types of data and documents (e.g. protocols, reports, and test procedures)
Assist in maintaining process KPIs and quality matrix as required
Drives alignment of the process with quality and compliance procedures
Serves as an effective member of the Laboratory Operations team and may serve as a mentor to other employees in the area of expertise
Performs floor inspections with focus on audit trail review and testing process/technique scrutiny as required
Provides support to release of materials (e.g. media, reagents) as required
Assists with continued improvement initiatives as needed
Assists with development/writing of SOPs, Work Instructions, and other documents and/or reports as needed
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 2+ years GMP related experience; OR Master's degree in related field with 1+ years related experience; OR equivalent education and work experience
Chromatography experience required
Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise
Excellent written and oral communication skills
Good math skills
Ability to be trained and to mentor others
Ability to act independently
Ability to interact well with employees at all levels
Proficiency with Microsoft Office products
Preferred
Method validation experience 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