David Davenport
Edgewater,NJ
Summary
Skilled machine operator with a focus on aseptic vial and syringe fill/finish operations. Extensive experience in aseptic processing across biotech and pharmaceutical manufacturing. Certified job trainer (ejot) with proven ability to perform skill block checks effectively.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Visual Inspector
RK Pharma
07.2024 - 09.2024
- Conducted visual inspections to ensure product quality and compliance with regulatory standards.
- Identified and documented defects, facilitating timely corrective actions.
- Collaborated with production teams to enhance inspection processes and improve efficiency.
- Trained new inspectors on best practices and inspection techniques for consistent quality assurance.
Operator II
Instrumentation Laboratory
07.2019 - 09.2021
- Maintains all production areas in clean and orderly manner and following cGMP practices.
- Completes work orders accurately detailed manner and all required records, logs, and documentation
- Runs multiple machines and troubleshoots any problems that may occur and complete changeover of parts if needed
- Immediately notifies team leaders or supervisor of all anomalies and requests assistance whenever production or quality issue arise
- Performs all duties assigned in safe manner while keeping quality standard and maintaining production pace
Capacity Operator
Colorcon
03.2018 - 03.2019
- Gather materials for batch using RF system
- Transfer drummed material into blenders and transfer product to different manufacturing areas while following all SOPs
- Transfer totes, tubs and other mobile equipment to various locations in production areas
- Clean and disinfect work areas by sweeping, mopping, cleaning equipment with bleach and caustic detergents, dismantling and reassembling equipment, entering confined spaces to scrub mill
- Operate various equipment and instrumentation safely, according to procedure and with little supervision. Equipment may include, but not be limited to 3 roll mills, blenders, bead mills, grinders, PLC's, and dryers
- Adhere to safety and quality protocols including, wearing hairnets, safety glasses, coverings and protecting materials
- Document all batch sheet data and cleaning logs using cGMP quality standards
- Stage finished products to shipping or transfer point
- Train other operators as needed
Quality Inspector
Tecomet
11.2017 - 02.2018
- Perform receiving, in-process and final inspection and developed inspection criteria
- Independently perform product layout inspections
- Instruct plant personnel in proper inspection techniques and procedures
- Audit paperwork, compile and maintain master device history records
- Repair and maintain gauges, measuring and test devices
- Perform CMM programming and troubleshoot & edited programs
- Adjust and prioriitize work to meet deadlines while maintaining quality of standards
- Work with customers and quality engineers on daily basis to resolve quality issues
Aseptic Vaccine Operator
Pfizer
09.1999 - 07.2016
- Monitored production, labeling, packaging and cartoning equipment used is syringe and vial for fill/finish
- Inspected finished product for minor defects and major non-conforming defects
- Maintain cleanliness of common work areas and manged inventory for consumables used in manufacturing process.
- Maintain logs and batch records
- Gown Certified
- Execute annual Media Fill evaluation to ensure manufacturing capability conformance when "out of spec" scenarios were presented; example; manufacturing in-process time exceeded, etc
- Ensure adherence to stringent SOP's: grade classifications of aseptic techniques include A, B, C, and D in clean room environment
- Transfer production and packaging supplies from holding areas to aseptic areas
- Perform component preparation, including: run daily operations, perform Leak and Bowie Dick testing on autoclaves, sterilize, unload wrap and tag sterilized parts and then place into storage
- Utilize equipment including: Eiasi inspector, capper, filler, heat sealer, Autoclaves, renester, denester, load stoppers for production runs
- spray and wipe down syringe nests for production
- Trained new personnel
- Escorted visitors around production area to ensure compliance with cGMP's and site policy
Education
TASC -
Rockland County BOCES
West Nyack, NY9 2016
CRCST Certification - Sterile Processing Technician
City College of New York
New York (City), NYSkills
- GXPharma
- AMPS
- MES
- Gown Certified
- Kronos
- Plateau
- Workflow Prioritization
- Quality Assurance
- In Process Checks(IPC)
- Continuous Improvement
- Product Verification Inspection
Languages
English
Native or Bilingual
Certification
- Gown Certified
Additional Information
- Part in process optimization focus groups to decrease down-time/ increase efficiency to reduce production cost.
- Received "Outstanding Aseptic Behavior and Techniques" recognition (based on personnel monitoring results) for being in the top 93% of personnel site-wide.
- Member of Improvement teams
- Trained in regulatory safety and compliance: FDA, OHSA, cGMPs, OSHA, cGMPs, SOPs, PMOs
Education
true
Accomplishments
CRCST certification
Timeline
Visual Inspector
RK Pharma
07.2024 - 09.2024
Operator II
Instrumentation Laboratory
07.2019 - 09.2021
Capacity Operator
Colorcon
03.2018 - 03.2019
Quality Inspector
Tecomet
11.2017 - 02.2018
Aseptic Vaccine Operator
Pfizer
09.1999 - 07.2016
TASC -
Rockland County BOCES
CRCST Certification - Sterile Processing Technician
City College of New York