Experience

Myonex

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Batch Record Reviewer

  • Oct 2022 - Present



Abzena

• Quality Specialist

  • Mar 2022 - Present



Philadelphia Animal Welfare Society

• Volunteer

  • May 2010 - Present

  Foster and train adoptable dogs. Conduct and coordinate fund raising events. Foster and train adoptable dogs. Conduct and coordinate fund raising events.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Specialist

  • Feb 2021 - Aug 2022

  • Performed 100% process document review for accuracy and completeness, including executed batch records, Elogs, logbooks, and SAP transactions. • Collaborated with IPT members to identify and implement continuous improvement initiatives and action plans. • Maintained tracking databases associated with review and coordinated with operations to resolve observations. • Performed SAP transactions to document batch record review. • Received and issued batch records for use in production. • Performed 100% process document review for accuracy and completeness, including executed batch records, Elogs, logbooks, and SAP transactions. • Collaborated with IPT members to identify and implement continuous improvement initiatives and action plans. • Maintained tracking databases associated with review and coordinated with operations to resolve observations. • Performed SAP transactions to document batch record review. • Received and issued batch records for use in production.



Adaptimmune

• United Kingdom
• Biotechnology Research
• 300 - 400 Employee

• Cell Therapy Manufacturing Specialist

  • Feb 2019 - Feb 2021

  • Developed deep understanding of processing patient apheresis using T-Cell Receptor (TCR) enhanced cell therapy, including cell expansion, culture maintenance, media prep and harvest in an aseptic environment, including use of Electronic Batch Records. • Worked to resolve issues in manufacturing by troubleshooting and writing deviations, CAPAs, and incident reports. • Reviewed, wrote, and modified master batch records and SOPs. • Lead and verified manufacturing team members and reviewed batch records to certify accuracy and quality of final product. • Verified accuracy of patient data in STARLIMS.



WuXi AppTec

• China
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Manufacturing Associate

  • May 2016 - Jan 2019

  • Performed tumor dissection, cell expansion, and harvest for TIL (tumor-infiltrating leukocytes) cell therapy client. • Authored complex SOP’s, work orders for maintenance, NCE’s (non-conformance events), and deviations. • Reviewed equipment and suite logbooks and batch records for necessary corrections. • Ordered materials via business portal or purchase orders. • Established visual inspection program for cell therapy product. • Track all metrology equipment and coordinate calibrations. • Had ownership of Cintas gowning, including receipt, counts, and coordinating changes to inventory and orders.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Biotechnician

  • May 2011 - May 2016

  Developed an expert-level understanding of all Rotavirus Bulk Processing operations (Cell Expansion, Media Prep, Infection, Harvest, Filtration, and Dispense) as well as any relevant support functions required to maintain production. Consistently and successfully executed any assigned tasks in a timely manner and according to appropriate SOP’s, MPD’s, or other approved documents, regardless of task complexity. Maintained professionalism and positive attitude in a team-based and diverse work environment at all times. Recorded and reviewed all written work according to proper cGMP documentation practices, championing Right First Time initiatives and maintaining a defect per page ratio of 0.25 Defects per 100 Pages. Provided subject matter expert and voice-of-customer insights for numerous SOP and/or Batch Record revisions, CR’s, CAPA’s, etc., authoring several SOP’s as needed. Trained in Proper Cleanroom Behaviors, including proper Aseptic Gowning & Sampling Techniques; with zero gowning excursions and 100% passing results on all process simulations. Demonstrated working knowledge of Environmental Monitoring program and tools, including discrete and continuous microbial air and particulate air sampling, as well as microbial surface testing and swabbing techniques.



JBS Packerland-Souderton

• Safety Manager

  • Feb 2009 - Sep 2009

  Reduced OSHA recordable injury rate by 25 % using behaviour based safety programs. Conducted OSHA training (lockout/tagout, hazard communication, powered industrial vehicle, fall protection, confined space, etc.) for Souderton plant (1300 employees). Created and implemented saw safety program. Investigated accidents to determine root cause and corrective actions and provide disciplinary recommendations. Performed environmental sampling for carbon dioxide (TSI Q-TRAK) and ammonia levels (Drager tubes). Acted as company liaison during unscheduled OSHA inspection and handled company response to citations. Created and chaired core team (department heads) and employee safety committee, developed a safety training program for both teams, and led weekly meetings for both teams. Created and maintained safety management database to track and resolve safety issues using maintenance work orders, training, Identified modified duty jobs to reduce workers comp rates. Monitored confined spaces during entry using MSA Altair 3 gas meter.



David Michael & Co.

• United States
• Food and Beverage Manufacturing
• 1 - 100 Employee

• Quality Systems & Safety

  • 2002 - 2009

  Conducted OSHA, GMP, GLP, Allergen, and HACCP training for entire Philadelphia facility (150 employees (50 union manufacturing, 50 lab, 50 office) and conducted monthly audits for GMP, HACCP, and security policies.Set up environmental testing protocol for hazardous substances including diacetyl, ethyl alcohol, acetaldehyde, and general VOCs and fit tested employees using qualitative fit testing method for half mask respirators and monitored confined spaces during entry.Managed hazardous waste disposal program, determined HMIS code for raw materials, coordinated DOT Hazmat training.Investigated accidents to determine root cause and corrective actions.Direct quarterly mock recalls of both raw materials and product.Chaired state-certified safety committee which met monthly, went on monthly inspections, and created work orders to make repairs or modifications to eliminate hazards

• Sample Technician

  • Jan 2001 - Jan 2002

  Compounded flavors in the laboratory to send to customers.



Fielco Industries

• Laboratory Technician

  • Jan 1999 - Jan 2001

  Assisted formulators in development of new adhesive products. Worked directly with Technical Director to solve technical issues. Created, maintained, and updated MSDS files of raw materials and finished product. Served as internal auditor for ISO 9000. Assisted formulators in development of new adhesive products. Worked directly with Technical Director to solve technical issues. Created, maintained, and updated MSDS files of raw materials and finished product. Served as internal auditor for ISO 9000.



Kawneer Co. Inc

• Quality Control Technician

  • Jan 1993 - Jan 1999

  Tested and maintained chemical levels in an aluminum anodizing system. Wrote work instructions for ISO 9000 certification. Served as communication liaison for departmental meetings. Tested and maintained chemical levels in an aluminum anodizing system. Wrote work instructions for ISO 9000 certification. Served as communication liaison for departmental meetings.