Thomas Bilotta Email & Phone Number

Lansdale, Pennsylvania, United States

West Point, Pa

Directly support Pneumovax bulk manufacturing performing investigations (iQN), Change Requests (CRs), Batch Record updates, and general support in the formulation process.

• Directly support the commercial bulk manufacturing of Gardasil and Recombivax• Indirectly support the commercial bulk manufacturing of Pneumovax, Vaqta, and the formulation and filling of all supported products• CR, MBR, and SOP approver representing operations• Request Management Team Manager for the BTM (Focus Factory)o Managed during FDA (Team Bio), TGA (Australia), EMA (Europe), MHRA (UK), COFEPRIS (Mexico), and Kenyao Managed during internal inspections including pre-PAIso Evaluated industry trends and previous inspections prior to inspectors arriving to look for trends and areas of focus• Facilitator for the Integrated Process Team (IPT) weekly meetingo Lead facilitator for the tactical and strategic meeting to assure the right discussions are taking place • Managed and Maintained Systems: o CAPA tracking o Commitment trackingo 3 year review SOPso Pest control program• LSS and Kata Methodologyo Mentor for BCAT and USW Compliance Team in yellow belt projectso Acted as a Kata coach for multiple teams to drive to appropriate and manageable actions• Behavioral Coach for human error investigationso Performed interviews with individuals involved in human error investigationso Updates to SOPs and Batch Records to reduce human errors and increase Right First Time documents.• Leader of the Building Safety Action Team (BSAT)o Led the team to increase safety awareness, proactive approach, and decrease incidentso Led multiple activities for safety awareness for the Focus Factory and Plant Site• Development and Delivering of training:o Compliance trainings to the shop floor to increase inspection readinesso Process improvements such as SOP or Batch Record updateso Simplification of processes that spanned multiple SOPs (example: closing a CAPA)o Worked with Learning and Development group on Onboard Training development• Deviation authoring for shop floor and systems a-typical events

Hatboro, Pennsylvania, United States

Pouring beers and listening to stories.

Ambler, Pa

Designed and teaching a 3 credit Aquaponics class pulling on personal experience, visits to facilities, and guest speakers in the industry.Designed and teaching a two different 4 week non/continuing ed Aquaponics class'

Ambler, Pennsylvania

Lead/Assist students in building and running multiple aquaponics exhibits at the temple ambler campus. Co-lead in the AALAC accredited lab.

Hatboro, Pennsylvania, United States

Aquaponics system and Education design

Hatboro, Pa

I manage the Facebook page, Twitter, Instagram, answer emails, assist with some brewing, and tend bar on Friday evenings. www.CrookedEyeBrewery.comTwitter/Instagram: CrookedEyeBrewswww.facebook.com/crookedeyebreweryEmail: CEBrewery@gmail.com

White water kayak instructing on the Lehigh River

ISO 9001, 14001, 18001, and 21 CFR Regulated FacilityResponsible for managing 8 QA Line Inspectors. This includes scheduling, monthly reviews, trainings and mentoring.Management the CAPA, NCR/DR, and Change Control processes and their metrics reported on a monthly basis.Represented Alcan during customer audits and worked with the management team to quickly and effectively respond to any and all observations.Represented the QA/QC department during an FDA audit.Frequently work with the Customer Service Department on items to improve relations with the customer.Managed monthly plant wide cGMP trainings.Author, review and approval of incoming and finished product specifications as well as batch record templates.Managed document control of SOP's owned by the quality group.Assisted in internal and external audits of Alcan and its suppliers.Represented QA in new product launches and smaller stability runs.Authored the Quality Management System Manual based on ISO 9001, 14001, 18001, and 21 CFR requirements.Green Belt Certification. Projects Included:Tube testing reduction equating to over $40K in annual savings.Carton waste reduction equating to over $30K in annual savings.Finished product weighing reduction equating to over $30K in annual savings.

Performed analytical testing on finished goods in compliance with SOP, cGMP, GLP, and FDA regulations.Extensive use of USP/NF for testing of raw materials used in final production.Utilized modern instrumentation (TOC, HPLC, GC, UV/VIS, FTIR, PSA) for qualitative and quantitative analyses following methods and quality standards.Performed in Safety Audit.Performed the review of multiple new raw material specifications for feasibility for the laboratory to test.Performed hold time studies on sample, increasing sample expiration and reducing the number of analysts needed to test. General reports in summary of analytical data using LIMS, EXCEL, and Empower.LATCP and HPLC Troubleshooting classes completed.Member of the Calibration Team. Performed calibration of TOC, HPLC, UV/VIS, FTIR, PSA, and Dissolution Rate Apparatus. Managed the stability program as coordinator, initiating and pulling studies to be tested.Assisted in installation of Millennium/Empower and multiple Part 11 compliant software upgrades for general use in the lab.Training analysts in testing procedures.

Analysis of medical gases by use of F.I.D. and T.C.D. G.C's

Masters Of Science, Education

Bs, Chemistry