David Carpenter
Garner,NC
Summary
Proven leader in biopharmaceutical manufacturing and quality control, with a track record of enhancing process efficiency and ensuring GMP compliance at National Resilience. Skilled in SAP and MES, adept at environmental monitoring and data integrity assurance. I excel in GMP implementation and process improvement, showcasing strong leadership. Achievements include enhancing sample management efficiency and spearheading cross-functional collaborations, significantly boosting operational compliance and productivity.
Overview
11
11
years of professional experience
Work History
Analyst II - Quality Control
National Resilience
10.2023 - Current
- Responsible for sample inventory management within QC, including sample aliquoting and discard, as appropriate
- Responsible for ensuring that sample management forms/documents adhere to GMP requirements
- Receiving and distribution of samples from manufacturing, including in-process samples and fill finish vials
- Process online order submissions for on and off-site testing
- Responsible for ensuring appropriate documentation is in place prior to sending samples to contract testing laboratories
- Preparation of samples in the BSC
- Proficient in aliquoting of samples, including quantity and volume per the sampling plan designated for each product
- Executed uploading and approvals of documents and forms in Veeva systems
- Manage the day-to-day operations of incoming and outgoing QC samples, ensuring a timely, effective, and compliant operation in support of manufacturing operations
- Establish and maintain a good working relationship with cross-functional representatives for receiving and processing samples submitted to QC
- Responsible for pulling stability samples at designated time points as per the stability protocol and stability pull schedule
- Experienced in using Novatek, creating plans and editing summaries for manufacturing and QC related work
Manufacturing Technician III
National Resilience
09.2021 - 10.2023
- Experienced working with scales
- Experience in using Vi-Cell
- Qualified in cell expansion as well as filling procedures
- Executed working and cleaning of the BSC (Bio Safety Cabinets)
- Experienced in working with Autoclave
- Started cycles in parts washer
- Experience in cell sampling, (WCB, MCB, HEK 293T, CTS LV MAX)
- Understands the importance of following SOP procedures and using correct GDP for Batch paper records
- Qualified in standardizing osmometer
- Qualified in standardizing Ph/conductivity meter
- Experience in aseptic techniques in Grade A
- Experienced in working with environmental plates (settle and rodac) and equipment
- (SAS, MET ONE, LASAIR)
- Aseptic Qualified Technician
- Aseptic Qualified in Master Cell Banking
- Aseptic Qualified in operations of a Biosafety Cabinet
- Visual Inspection qualified
- Experienced in fill finish
- Aseptic process simulation qualified for fill finish
- Proficient in interventions performed in Isolators and BioSafety Cabinets
- Experienced in PPQ (Process Performance Qualification)
- Proficient in cell expansion passages and vial thaw
- Experienced working with water baths and Thaw Star
- Performed batches using batch paper records
- Perform and execute work orders in BMRAM
- Proficient in working in cell gene therapy manufacturing floor
- Experienced in investigating and closing deviations and CAPAs
- Executed work instructions for SOP updates
Manufacturing Technician II
Merck Inc
10.2018 - 09.2021
- Check the equipment and materials on a regular basis to ensure it is used properly, in order to maximize productivity
- Perform daily inspections of work area to ensure safety of co-workers
- Review and record any fail grade of the product being inspected
- Set-up & breakdown of Good Manufacturing Practices, space/equipment, accurate & efficiently moves process materials in accordance with procedure
- Operate large scale manufacturing equipment
- Trained in cleaning aseptic environments
- Aseptic gowning qualified
- Perform a multitude of tasks under aseptic conditions
- Execute validation protocols under supervision/direction of others
- Labeling & Inventory management of clean/sterile equipment
- Perform peer review of batch records to minimize human error
- Environmental Monitoring qualified
- Experienced in SAP and proficient in G-LIMS
- Assisted troubleshooting of automated inspection machines and capper equipment
- Proficient in electronic batch records and manufacturing execution system
- Accurately maintain, package and transport products, materials, and equipment
- Ensures that all required documentation to support products and accountability is accurate
- Promoted to level 2 after one year as level 1
Crew Leader
Big Lake Landscaping
06.2017 - 10.2018
- Managed a crew of 3-5 co-workers to coordinate jobs
- Performed each task with focus on quality
- Maintained a clean and safe work environment
- Completed weekly service on commercial and residential properties
- Fueled vehicles and equipment daily
- Mow, edge, lay mulch down, trim shrubs and trees
- Assisted in building hardscapes including stone and brick walkways, patios, retaining walls, and fences
- Sharpened blades on all mowers
- Change oil and filters on all equipment
Shift Leader
Walgreen’s Drug Store
03.2015 - 05.2017
- Managed team of 20 or more employees
- Reduced store losses by completing damaged and stolen counts daily
- Increased sales by setting new marketing displays
- Balanced daily cash deposits and safe count with zero error rate
- Prepared daily invoices
- Trained employees on cash drawer operations
- Supplied tellers with coin and currency as needed
- Directed specific questions and phone calls to appropriate personnel
- Delivered prompt, accurate and excellent customer service
- Received change order and enter into computer properly
Shift Leader
Riff’s Burger’s and Blues
06.2014 - 03.2015
- Supervised staff of 15-20 employees
- Created work schedule for all employees
- Trained employees on POS (Point of Sale) systems
- Delivered exceptional customer service to all patrons
- Helped revise menu, including drink and food specials for the day
- Exhibited thorough knowledge of foods, beverages, supervisory duties and guest interactions
Education
Bioworks certificate program -
Johnston Community College
08.2018
HIGH SCHOOL DIPLOMA -
Clayton High School
Clayton06.2009
Skills
- SAP
- MES
- MS Word
- Environmental Monitoring
- Grade A Isolator
- BioSafety Cabinet
- Single-use compounding
- Filling components
- Batch record review
- Sample Inventory
- Contract testing labs
- Data integrity assurance
- Process improvement
- GMP implementation
References
References available upon request.
Timeline
Analyst II - Quality Control
National Resilience
10.2023 - Current
Manufacturing Technician III
National Resilience
09.2021 - 10.2023
Manufacturing Technician II
Merck Inc
10.2018 - 09.2021
Crew Leader
Big Lake Landscaping
06.2017 - 10.2018
Shift Leader
Walgreen’s Drug Store
03.2015 - 05.2017
Shift Leader
Riff’s Burger’s and Blues
06.2014 - 03.2015
Bioworks certificate program -
Johnston Community College
HIGH SCHOOL DIPLOMA -
Clayton High School
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