Tarsha Worthington
Nashville,NC
Summary
Dynamic Bioprocessing Technician III at Humacyte Global with a proven track record in leading manufacturing activities and enhancing processes. Skilled in SAP and quality assurance, I excel in communication and teamwork, driving compliance with cGMP standards while mentoring team members to achieve operational excellence.
Overview
33
33
years of professional experience
Work History
Bioprocessing Technician III
Humacyte Global
Durham, NC
06.2024 - 10.2026
- Lead daily manufacturing activities for production of regenerative tissue-engineered vascular products, working independently within established SOPs, BPRs, and cGMP requirements
- Serve as hands-on manufacturing resource, leading production activities, equipment setup, assembly, operation, disassembly.
- Trained and mentored team members on critical manufacturing tasks, equipment operation, and process requirements to enhance team competency.
- Troubleshot mechanical and atypical process issues, ensuring minimal downtime and maintaining production flow.
- Revise and execute Standard Operating Procedures (SOPs) and Batch Production Records (BPRs) while ensuring accurate and compliant documentation skills
- Supported process improvement projects by training new employees on best practices and operational procedures.
- Ability to work effectively in a team environment while demonstrating strong verbal and written communication skills
Production Operation II
Liquidia Technology
Raleigh, NC
09.2023 - 06.2024
- Monitored manufacturing process, documenting observations and key parameters to facilitate quality control.
- Executed SOPs for manufactured equipment support, ensuring operational consistency.
- Troubleshoots equipment issues for deviations and CAPAs.
- Adhered to GLP and GMP guidelines, maintaining compliance in laboratory practices and enhancing regulatory standards.
- Collects samples for testing and inspection activities.
- Performs experimentation alongside internal Engineers and other scientific staff.
GMP Research Analyst I
Duke Neurosurgery Research Medical Lab
Durham, NC
08.2022 - 09.2023
- Manufactured cellular products for clinical trials, ensuring compliance with regulatory standards.
- Conducted quality testing for endotoxin levels and gram staining to meet quality assurance protocols.
- Prepared and qualified reagents, stains, solutions, chemicals and culture media.
- Accurately completed batch record documentation.
- Operation of equipment used for cell manufacturing cell separators, cell counters, microscope, centrifuge, incubators, pipettes, BSCs, parts washer, autoclaves
- Performed weekly and or daily environmental monitoring.
- Maintained accurate inventory records to support efficient operations in production. of materials and products used in production to support efficient workflow.
Manufacturing Operator (Contract)
Biogen Pharmaceuticals
Durham, NC
10.2018 - 06.2019
- Reviewed and approved production batch records; conducted visual inspections to maintain product quality standards.
- Conducted line clearance to ensure proper equipment setup and accuracy of label verification.
- Investigated out of range percentages to identify and eliminate potential product line contamination.
- Followed SOPs, GMPs and FDA regulations.
Quality Assurance Documentation Specialist (Contract)
Micell Technologies
Durham, NC
05.2018 - 10.2018
- Strong understanding of documentation security principles
- Highly organized with focused attention to detail
- Excellent interpersonal and oral communication
- Able to work both independently and in team environment
- Above-average auditing skills
- Tracked documentation systematically to enhance accuracy and ensure accessibility.
- Maintained company documents, including employee training records, to support compliance and training initiatives.
- Completed file audits and requested missing documentation
- Coordinated document retrieval and archiving with third party vendor to streamline access to records.
- Followed SOPs, GMPs and FDA regulations
Manufacturing Technician (Contract)
Sandoz
Wilson, NC
04.2016 - 01.2017
- Operated, troubleshot, and maintained manufacturing equipment, including cleaning and changeovers, to ensure optimal performance.
- Operated compression equipment in compliance with FDA regulations and corporate policies.
- Recorded and reconciled batch-related information, documented GMP and SOP activities, and performed quality checks to maintain product integrity.
- Identified and corrected errors, oversights, and incomplete data to ensure accuracy and compliance.
- Led the design manufacturing process for multiple excipients and active raw materials, producing a finished dosage form for the consumer.
Quality Assurance Documentation Specialist (Contract)
Becton Dickinson & Co.
Wilson, NC
04.2015 - 04.2016
- Acted as the primary Document Control contact for generating, revising, numbering, and routing approval, storing, and archiving of critical controlled documents for engineering, automation, validation, and master batch records for manufacturing documents at the BD Rx Wilson site and BD PPH in Pont de Claix, France.
- Reviewed and executed Document Issue Forms for all QC chemistry, laboratory, and Microbiology.
- Supported internal audits, collaborating with Regulatory and Customer teams to identify and implement corrective actions.
- Assisted in monitoring and supporting calibration and validation maintenance program files.
- Migrated documents from QDMS to SAP system, ensuring formatting consistency and integrity of critical document tracking.
- Organized and maintained documentation filing system, enhancing accessibility to critical documents.
- Wrote and implemented SOPs and Work Instructions.
- Developed and maintained cGMP logbooks for BD Rx associates, ensuring proper documentation practices.
- Followed written procedures and policies committed to high-level attention to details assuring processes were performed in compliance with Good Documentation Practice (GDP), current Good Manufacturing Practices (cGMPs), and Standard Operating.
Packaging Technician and Training Associate (Contract)
Glaxo Smith Kline
Zebulon, NC
04.2014 - 04.2015
- Trained employees on inspection procedures for Oncology Drug Tafinlar, enhancing team capability
- Conducted inspections of components to ensure quality compliance and unloaded components
- Conducted quality checks, documented findings, and addressed discrepancies
- Reconciled batch records to ensure accuracy and compliance
- Adjusted machinery settings to optimize performance
- Change over equipment cleaning to include troubleshooting
- Followed SOPs, JSAs, GMPs and implemented JDI's
Manufacturing Operator (Contract)
DSM Pharma
Greenville, NC
11.2013 - 04.2014
- Disassembly, reassembly and operation of critical compression equipment in compliance with FDA regulations and corporate policies to manufacture solid dose-controlled substance.
- Executed SOPs, JSAs, and cGMPs to ensure compliance.
- Cleaned and repaired equipment to sustain operational efficiency and reliability during production.
- Performed in process-sampling, calculations, critical measurements and weights for production needs.
- Conducted inspection to verify product quality and compliance. and ERH testing on products compressed.
- Identified errors and gaps in batch information records, ensuring data integrity for compliance.
- Ensured all components were gathered in support of manufacturing the product.
Manufacturing Production Technician
Merck Sharp & Dohme Co.
Wilson, NC
08.2011 - 11.2013
- Coordinate, disassembled, reassembled, operated and led activities of the hand automated and semi-automated packaging lines
- Operated packaging equipment within qualified parameters
- Conducted quality checks during production processes
- Oversaw product quality for all packed products, ensuring adherence to quality standards
- Maintained logbooks and conducted internal audits to ensure compliance and operational integrity
- Performed and documented equipment challenges per current procedures
- Ensured compliance with OSHA rules and regulations
- Adhered to standard operating procedures for safety, GMPs and FDA regulations
Manufacturing Operator
Glaxo Smith Kline
Zebulon, NC
06.2003 - 08.2011
- Disassembly, reassembly and operation of critical compression equipment in compliance with FDA regulations and corporate policies to manufacture solid dose-controlled substances. Followed SOPs JSAs, cGMPs and completed JDIs.
- Identified errors, oversights and incomplete data record batch information.
- Performed in process-sampling, calculations, critical measurements and weights for production needs.
- Inspected and conducted ERH testing on compressed products to ensure quality standards.
- Ensured all components were gathered in support of manufacturing the product
- Equipment cleaning to include repairs and troubleshooting
- Ordered and returned material to warehouse; scanned barcodes using SAP system
- Achieved forklift licensing to ensure efficient material handling.
Packaging Operator (Contract)
Glaxo Smith Kline
Zebulon, NC
08.2000 - 06.2003
- Disassembly, reassembly operation and sanitation of critical packaging equipment in compliance with FDA regulations
- Loaded components to support seamless assembly line operations.
- Ensured labels were printed and applied properly to products
- Conducted in-process testing, including leak, torque, and sampling tests on produced products.
- Recorded batch related information
- Reconciled batches and performed quality checks to ensure compliance with standards.
- Followed SOPs JSAs, cGMPs and completed JDI's
Production Technician (contract)
Granutech Production Tech
Wilson, NC
08.1996 - 08.2000
- Took multiple excipients and active raw materials through a design manufacturing process.
- Operated and troubleshot manufacturing equipment, documented activities and performed quality checks
- Disassembled and reassembled critical compression equipment in compliance with FDA regulations
- Identified errors and oversights in batch record data, enhancing accuracy and compliance
- Reviewed and verified batch records, ensuring accuracy and completeness to meet regulatory standards
- Performed cleaning and maintenance on equipment, ensuring optimal operation through effective repairs and troubleshooting
- Followed SOPs, GMPs and FDA regulations
Production Operator (contract)
Abbot's Laboratories
Rocky Mount, NC
01.1994 - 08.1996
- Packed and inspected pharmaceuticals to ensure quality and compliance
- Adhered to SOPs, GMPs, and FDA regulations to maintain operational standards
- Eliminated rejected materials according to safety protocols
- Managed inventory of rejected materials using computer systems for accurate tracking
- Visually inspected and packed IVs (inventoried)
- Safely disposed of contaminated syringes following disposal guidelines
Education
Bioworks Certificate -
Wake Technical Community College
Raleigh, NC01-2008
H.S. Diploma -
Southwest Edgecombe High
Pinetops, NC01-1992
Skills
- Effective communication
- Leadership development
- Time management
- Cross-functional collaboration
- SAP software
- Process validation
- Microsoft Office Suite
- Quality assurance
- Regulatory audits
- FDA regulations
- Clean room practices
Timeline
Bioprocessing Technician III
Humacyte Global
06.2024 - 10.2026
Production Operation II
Liquidia Technology
09.2023 - 06.2024
GMP Research Analyst I
Duke Neurosurgery Research Medical Lab
08.2022 - 09.2023
Manufacturing Operator (Contract)
Biogen Pharmaceuticals
10.2018 - 06.2019
Quality Assurance Documentation Specialist (Contract)
Micell Technologies
05.2018 - 10.2018
Manufacturing Technician (Contract)
Sandoz
04.2016 - 01.2017
Quality Assurance Documentation Specialist (Contract)
Becton Dickinson & Co.
04.2015 - 04.2016
Packaging Technician and Training Associate (Contract)
Glaxo Smith Kline
04.2014 - 04.2015
Manufacturing Operator (Contract)
DSM Pharma
11.2013 - 04.2014
Manufacturing Production Technician
Merck Sharp & Dohme Co.
08.2011 - 11.2013
Manufacturing Operator
Glaxo Smith Kline
06.2003 - 08.2011
Packaging Operator (Contract)
Glaxo Smith Kline
08.2000 - 06.2003
Production Technician (contract)
Granutech Production Tech
08.1996 - 08.2000
Production Operator (contract)
Abbot's Laboratories
01.1994 - 08.1996
Bioworks Certificate -
Wake Technical Community College
H.S. Diploma -
Southwest Edgecombe High