• Worked as a technical writer in the quality assurance department
• Senior consultant onboarded to review backlog of supplier change notifications to determine what department they affected and if the were acceptable
• Authored reports of the finalized and approved changes and filed them in the event of a regulatory audit

Worked as a technical writer in the quality assurance department
Senior consultant onboarded to review backlog of supplier change notifications to determine what department they affected and if they were acceptable
Authored reports of the finalized and approved changes and filed them in the event of a regulatory audit

Onboarded remotely to support with fast paced Operation Warp Speed project for J&J vaccine manufacture
Coordinate and maintained movement of materials and work instruments between Emergent and client needed for manufacturing fills
Worked with production planning and inventory control of materials management to ensure QA needs were fulfilled
Ensured system master data was accurate for materials; processed required transactions in SAP
Reviewed and approved all material technical documents submitted by manufacturers/suppliers to ensure compliance

Authored extensive reports of control data used in assays as part of QC stability program–trended and analyzed data using JMP for statistical analysis. Performed investigations and wrote deviations when control data was not within acceptable upper and lower limits
Provided technical services to QC laboratories, including qualification and validation of analytical instrumentation, method validation, periodic review, and generation of QC method control charts
Supported data entry and verification from LIMS, SAP and paper documents for each control condition

Core project team member responsible for start-up, commissioning, and qualification of Bayer’s new $101 million dollar GMP QC testing facility, including preparing technical documents required for regulatory approval
Worked cross-functionally with all departments affected by the project to resolve a wide range of issues, including facilities/utilities, QC, QA, validation/C&Q team, regulatory affairs, etc
Developed project plans—including master validation plan, consisting of method validation, tech transfers, etc
Developed/optimized GMP documents such as risk assessments, impact assessments, user requirement specifications, SOPs, etc.
Coordinated the procurement, delivery, installation, and commissioning and qualification of analytical instruments, standalone temperature controlled units as well as ensuring lab requirements met for transfer
Developed, maintained, and tracked project schedules; provided project schedule updates

Assisted in the start-up of cGMP and QA/CMC systems, including authoring, reviewing and approving SOPs, qualification and monitoring protocols, validation protocols, product/material specifications, annual product reviews, change controls, deviations and investigations, CAPAs, root cause analysis, internal audits, QC protocols and testing methods, transfer and stability protocols and more
Assigned batch records for manufacturing runs and reviewed and approved all documents for batch record disposition
Responsible for releasing commercial product, raw materials and components, disposition and material handling
Created and maintained maintenance schedules, including validations, requalifications, etc
Created and maintained stability program based on protocols
Provided employee training and updated records

• Performed routine calibrations on equipment used for fermentation, drug manufacturing and production (bioreactors, blow/fill/seal machine, CIP/SIP systems, protein purification systems, etc), QC, R&D and microbiology labs. Calibrated building maintenance system components (differential pressure, gasses, TOC, etc), purified water systems (WFI/RODI) and compressed air systems and more
• Performed IQ/OQ/PQs on new and existing lab instruments as well as manufacturing equipment such as sterili[ers, glass washers, etc
• Maintained all records of past calibrations/validations and independently prepared for and managed upcoming calibrations and validations
• Partnered and coordinated with department managers/supervisors to ensure availability of instruments due for calibration and maintained no loss of time

Tested APIs and final drug product using analytical instruments such as HPLC, GC, FTIR, Karl Fisher, etc