Guy Macina
Middle River, MD 443-***-**** **********@*****.***
Confident, ambitious and energetic Analytical Professional with years of dynamic career experience. Seeking a QA Analyst 2 role that will allow for professional growth and use of transferable skills. Adept at working under pressure to achieve goals, both independently and in teams. Excel to keep processes running smoothly with little to no direct supervision. Able to deliver high-caliber results in deadline-driven environments. Determined with a strong work ethic and attention to detail, always willing to enhance knowledge base.
CORE COMPETENCIES
Quality Assurance, Analyst Skills, Leadership, ISO/cGMP Compliance Documentation Issuance & Control, Customer Service, Communication, Cross-Functional Collaboration, Teambuilding, Client Relations, Project Management, Internal Audits, Kronos, Microsoft (Excel, Word, Teams, PowerPoint, SharePoint), SAP, eDMS (eDOCs, Veeva)
EXPERIENCE
Emergent BioSolutions LLC Analyst (2020 – 2023)
Adhered to CGMP, along with corporate policies, specifications and best practices
Created and dispensed batch records containing all the necessary documents and data to produce client-specific pharmaceuticals
Acted as System Administrator to oversee departmental logbooks and issue/distribute laboratory notebooks
Executed document control operations such as filing, scanning and archiving
Gathered and presented statistical trends via monthly batch record metrics and document change requests
Developed and distributed site-specific GMP documents to support production
Upheld proficiency in MS Office, mastering how to communicate verbally and in writing with staff across locations
Helped assemble performance metrics for Document Control purposes
Engaged actively in Six Sigma training to enhance process improvement skills and tools
Collaborated with relevant departments to ensure compliance with serialized control copies
Demonstrated expertise in CAPA tasks and Effectiveness Checks
Updated SOP manuals as documents were marked effective
Entrusted as a technical guide to deliver end-user assistance and support; delivered training to EMDS users and kept all EDMS training materials updated
The Manor Assistant General Manager (2019 – 2020)
Delivered first-class customer care by addressing concerns with timeliness and empathy
Authored sales and inventory reports via Excel using data gleaned from revenue
Alchemy Elements Restaurant Server (2016 – 2019)
Offered top-tier customer service, swiftly recording transactions in MICROS to keep service timely
Excelled cross-functionally within other restaurant areas, fielding telephone correspondence and finalizing staff financial transactions