Degreed bioprocess technician with experience in a regulated pharmaceutical manufacturing environment, with a robust and dedicated work ethic to safety, regulations, productivity, quality, and teamwork.

Qualifications

Trained in pharmaceutical CRF and cGMP in areas of processing and packaging

Ability to assimilate complex process-oriented SOPs

Use of CAPAs as well as 4 quads to reduce quality notification errors

Executes complex robotic processes and required documentation steps in the electronic batch record

Skilled in EM methodology and necessary documentation

Leads safety and team production meetings

Collaborates with variety of departments within the organization to solve problems such as automation, mechanics, and deviation management

SAP and LIMS experience for ERP

Proficient in Microsoft Office Suite

Versed in machine operator interfaces such as DeltaV and labeling machinery

Skilled with electronic batch record software such as MES (PAS-X Werum)

Eager to constantly learn new areas to provide value to my employer such as taking the impetus to become label verification technician at Grifols requiring multitasking to setup and run labeling and carton machinery

Resolved large scale packaging errors and ensured future labeling errors were detected

Work Experience

Merck Jan 2016 – Present

Bioprocess Technician

.During production downtime coordinated relabeling project to provide proper GMP information on new labels allowing for efficient and prompt shipment to the proper market

.Executes complex detailed processes to harvest viral fluids with precision

.Aggregates machine fault data and performance maintaining appropriate work orders necessary for production

.Set up robotic configurations using DeltaV and Staubli robotic systems

.Consistent in executing cellular fermentation production process with thousands of robotic aseptic manipulations on 12 hour or more shifts

.Created team resulting in decreasing EM deviations from 4.2 per batch to less than 1

.Qualified to train personnel within the viral production process

.Proof reads MES batch record for completeness.

.Creates shift reports for team members ensuring smooth transition onto the next shift

.Troubleshot machine faults to maintain proper timing in process

.Executes waste inactivation procedures using steam machinery in a safe and effective manner

.Implemented tool to increase efficiency of Wheaton Cart cleaning

.Uses SAP to run weekly inventory control documentation and reports

.Gowns to grade A specification daily never receiving contamination hit over 500 times

.Participates in the ethics established at Merck and its inclusive behaviors

.Complete decontamination to proper standards

.Meets strict production time schedules

.Performs environmental monitoring including sampling personnel and work space for viable as well as non viable samples using particulate monitoring systems such as PMS and Lasair

Cree Jul 2015 – Dec 2015

Production Technician

.Performed etching procedures to determine free sI in powders using a precise hydrofluoric acid and nitric acid mixture using great caution as HF is highly toxic

.Interfaced with MES ERP software for inventory and production

.Executed procedures at a technical level beyond basic operators

.Participated in updating and improving SOPs and creating consistent procedures for ultimate takeover by operators

.Planned daily scheduling requirements based on production unit needs

.Performed stringent lab work needing detailed consistent data and reliable results

.Calibrated equipment according to schedule

.Purchased calcium gluconate gel in the absence of site provided remedy for HF burns

Merck Manufacturing Division Apr 2015 – June 2015

Bio Process Technician Temp to Hire under Spectraforce

.Troubleshot machine faults relating to peristaltic pump flow rates, media, and beadfeeder faults, and other robotic issues to maintain schedule adherence

.Gowned to grade A specification daily never receiving a contamination hit

.Trained in proper aseptic clean room behaviors and techniques

.Interfaced with electronic batch record to ensure all functions were complete to proper standards

.Met strict production time schedules

Grifols Therapeutics Inc. (GTI)

Label Verification Technician Feb 2015 - Apr 2015

.Reconciled label counts, vial counts, and ensured proper documentation associated with the batch production record and reconciliation sheets

.Consistently prepared labeling machines to code for multiple markets

.Ensured packaging machines operating and assembling products according to FDA requirements

.Provided samples of appropriate cartons, leaflet inserts, lot, and date formats for each batch

.Operated Serpa labeling and cartoning machines

.Input labeling machine data including correct lot number, exp. date, and other appropriate data for bottle, and carton labeling for thousands of products daily

.Troubleshooted labeling and cartoning machinery to avoid faults and keep production steady

.Responsible for proper shrinkbanding of product and all necessary packaging elements that encompass a finished product for public sale

Package Line Inspector Sep 2014 - Feb 2015

Certified inspector passing the visual vial inspection test on first attept

Knowledge of cGMP with emphasis on CFR especially as it relates to CFR title 21 section 211.122

Unloaded Automatic cage unloader, operated Wexxar box making machine and pallet lifts

Assembled components at demanding rates up to 60 per minute

Maintained and ensured proper sanitation and cleaning of equipment

Responsible for documentation of packed product and BPR

Strict adherence to SOPs allowing safe distribution of final products

Talecris Plasma Resources, Grifols Plasma Organization Dec 2013 - Sep 2014

Donor Processor

.Selected for Donor Processor lead prior to promotion to GTI production

.Responsible for processing donor paperwork and charts

.Calibrated digital refractometers, centrifugal hematocrits, and scales daily

.Interfaced with donor population by guiding through the donation process providing assistance to donors in need of information or help donating

.Consistently and successfully performed precise donor screening processes

.Daily disposal of bio hazardous waste

.Maintained compliance with all State and Federal code

.Maintained supplies necessary to perform job duties

.Strict adherence to SOPs and standard practices to ensure traceability

Education

B.A., Political Science with a Minor in Economics

NC State University, Raleigh, NC

BioWork Certification, Wake Technical Community College

Validation Documentation Course NCSU Capstone BTEC center

Preparation and Purification course of Biological Samples for HPLC Analysis at NCSU Capstone BTEC center

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