Shayla Johnson
Raleigh,NC
Summary
Dynamic professional with extensive experience at Novo Nordisk, excelling in sample management and LIMS data entry. Proven track record in enhancing regulatory compliance and process improvement. Adept at inventory procurement and fostering collaboration across teams, ensuring optimal functionality and adherence to GMP standards. Strong analytical skills combined with effective communication abilities.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Sample Management Coordinator- OFP
Novo Nordisk
Durham, NC
06.2023 - Current
- Managed sampling schedule, anticipated needs, and communicated effectively with all stakeholders to ensure timely sample availability.
- Collaborated with quality control (QC), quality assurance (QA), environmental monitoring (EM), and supporting teams to ensure compliance with approved sample management protocols.
- Assist in updating the Sample Plan in gLIMS for both PV and Commercial batches.
- Initiate batch creation in gLIMs.
- Input data from the batch record into the LIMS system.
- Enter data from the Master Batch Record (MBR) into the Laboratory Information Management System (LIMS).
- Execute updates for Sample Logs.
- Managed the procurement of supplies for the Bulk team using the Coupa System.
- Coordinated resources to align with manufacturing schedules and maintain optimal functionality of the sample process.
- Set up & maintain 5S standards for Sample Management area.
- Suggests & implements process improvement & standardization updates.
- Completed additional tasks assigned by management to support team objectives.
- Partner & collaborate closely with local colleagues.
- Knowledge of US regulations & guidelines in reference to sampling plans & methods & application of GMP’s.
- Follow all safety & environmental requirements in the performance of duties.
- Obtained samples for further analysis.
Quality Control Analyst III and Safety Committee Member
Medicago
Durham, NC
10.2018 - 04.2023
- Managed sample intake, organization, and tracking for in-process and drug substance samples, facilitating routine, non-routine, stability, and retain testing.
- Managed receipt, log-in, retention, and disposition of QC and retain samples.
- Maintained sample inventory while coordinating stability schedules and third-party shipments for timely analysis.
- Oversaw Sample Management Program to ensure compliance and enhance organizational efficiency.
- Performed aseptic aliquoting and sample preparation; operated and maintained laboratory equipment including Class II Type A2 biosafety cabinets.
- Operated and maintained laboratory equipment, including Biosafety Cabinets (Class II, Type A2).
- Acted as the point of contact for third-party testing shipments and submissions.
- Updated schedule for stability pulls.
Quality Assurance Specialist II
Medicago
Durham, NC
06.2014 - 10.2018
- Performed QA Internal Audit/Walkthrough Inspection for GMP and Compliance.
- Investigated CAPAs and RNC (Deviations/Nonconformances) related to documentation control issues, enhancing regulatory adherence and process reliability.
- Coordinated MasterControl Electronic Document Control Management System, streamlining document retrieval and compliance tracking.
- Issued batch numbers for production records, ensuring traceability and compliance.
- Managed reconciliation process for issued logbooks, ensuring accuracy and compliance.
- Revised QA documents owned by QA document control for phase 2 and 3 campaigns.
- Provided and created logbooks, SOP-controlled binders, and metadata-controlled forms for manufacturing departments.
- Maintained quality records (training) in the document control room.
- Complied with 21 Code of Federal Regulations (CFR) 11 regulations.
Education
Associate of Science - Biopharmaceutical Technology
Wake Technical Community College
Raleigh, NC12.2016
Skills
- Sample management
- LIMS data entry
- Quality control
- GMP compliance
- Regulatory compliance
- Batch record management
- Process improvement
- Document control
- Inventory management
- Inventory procurement
- 5S and workplace organization
- Aseptic technique
- Data entry
Certification
Safety Committee Member (Medicago)
Timeline
Sample Management Coordinator- OFP
Novo Nordisk
06.2023 - Current
Quality Control Analyst III and Safety Committee Member
Medicago
10.2018 - 04.2023
Quality Assurance Specialist II
Medicago
06.2014 - 10.2018
Associate of Science - Biopharmaceutical Technology
Wake Technical Community College