Quality Assurance Inventory Specialist

Anthony Brennan

** ****** ****** ***. * Acton, Ma 01720 774-***-**** ***********@*****.***

SUMMARY: Experienced Manufacturing operator and Quality Assurance specialist with over 20 years of GMP experience. Solid knowledge of bioprocesses and GMP requirements.

EXPERIENCE:

inventory specialist

commonwealth Fusion systems:Devens Massachussetts

July 2024-September 2024

supporting manufacturing process through as member of the inventory team. Performing cycle counts,kitting, on floor delivery of kits,internal transfers, putaways.

Odoo

Quality Operations specialist 2

Thermo Fisher: Lexington Massachusetts

August 2023-March 2024

Supporting production activities on the floor.

Coordinate closure of GMP documents to support batch record closure and lot disposition of bulk record closure and lot disposition of bulk substance and drug product.

Approval of out of service and quality hold tag out.

Review of BMRAM work orders/NCR's

Review equipment logs in MES for accuracy and completeness.

Participating in functional area reviews and ensuring departments focus on continuous improvement.

Performing batch record review and preparing documentation for lot disposition by management.

Issue batch records and/or labels for emergency requests to support production.

Provide real time feedback for on the floor MFG staff

Perform walk through of production area

Escalate to supervisor any GMP issues as required.

Working effectively with people, including good investigation, problem solving and organization skills.

Initiating devevations through Trackwise and Triage, and updating manufacturing during shift exchange.

Performing Process improvements through change controls and CAPA.

MES,PAMS, SAP, Trackwise, Triage, documentum, blue Mountain,LIMS

Visual inspection of incoming bottles used for the manufacturing process.

Senior Manufacturing Tech cell therapy

Bristol Myers:Devens,MA.

November 2021- August 2023

Performing engineering runs for cell therapy validation. Using Delta V and MES systems for engineering trial runs. Using Welders,sealers, Sepax and Xuris. Performed activation,harvest, Transduction and inoculation Pipetting and sampling using celimiter and Xuri.

Revision of SOP's

Writing SOP from scratch.

Product impact deviation investigation.

Change control and CAPA

Reviewing electronic and paper batch records

SAP

Reviewing technical reports for Ramp operations for spelling and documentation eras.

Manufacturing Tech II

Takeda Pharmaceuticals: Lexington, MA

March 2016- November 2021

●Performing cell culture roller bottle operations. Sanitizing bottles, feeding robots and placing them on roller racks.

●CIP & SIP of media and harvest hold tanks and robot transfer line

●Cleaning of UF Skid. Through CIP and water washes and end of process sampling of OH and conductivity

●Post use Filter testing and the end of every process.

●Checked status logs log books and batch records at the end of every shift Sap for parts tracking and inventory.

Senior Manufacturing Tech

Genzyme: Alston, MA

June 2014- March 2016

●Microfiltration process in the purification capture group.

●Operation of the microfiltration skid.

● Sampling and testing of PH and conductivity.

●Transfer of the product to the column group after successful passing PH and conductivity

●CIP of tanks using Delta V

●Standardization of PH and conductivty meters before process

●Post Filter Testing after every process

●COP of dirty parts using caustic tanks

●SAP to track parts and inventory

●Reviewed batch records logbooks and status logs during concent decree

Senior Manufacturing Tech

Thermo-Fisher: Bedford, MA

September 2013- June 2014

●COP cleaning of tanks prior to process. Locking down tanks and using WFI

●Filled cones with final product after cones were inspected

●Cleaned tanks through pre-transfer washes using Delta V recipes

●Weigh and dispense of chemicals used for tank washes used Delta V to transfer products from preparation tanks to final product tanks

●GLP

●Delta V

●5`s systems

Manufacturing Operator II

Shire Human Genetic Therapies: Cambridge, MA

July 2007– September 2013

●Cleaning of UF skid using CIP and water runs. Tested PH and Conductivty to make sure Skid was clean

●CIP & SIP of media prep tanks and hold tanks before media batching and transfers. As well as Robot transfer lines.

●Weigh and dispense for Buffer and media teams in order to help them start their mixes on time.

●Operations glass wash to clean parts for all of the groups. Autoclave of small parts that needed to be sterilized for certain processes

●Monitor cell culture bioreactor overnight.

●Troubleshooting using an online system to start and stop bioreactor perfusion cycles and change parameters as needed.

●cleaning of aseptic hoods before roller bottle started their process

●Review batch records, logbooks and status logs. Completing the manufacturing portion of the review before handing documents of to QA Initiate emergency work orders. By filling out emergency work order forms and presenting them to on shift mechanic when equipment broke overnight

●Helped with deviations by interviewing and discussing the events with less experienced members of the team and assisted them in filling out the manufacturing portion of the forms.

● Ordering and checking materials as well as filling out forms for materials such as acid and caustic, as needed overnight

Safety Technician

Veolia Environmental: Cambridge, MA

September 2005 – July 2007

●Hazardous waste containment and processing: bio-waste removal from suites

●Cleaning of chemical satellites by removing hazardous chemical when they become to full.

●Containment of hazardous chemicals safety inspection for lab workers by conducting weekly safety walk throughs

●Chemicals decontamination cleanings of chemical spills

Manufacturing Operator

Stryker Corporation: Hopkinton, MA (contract)

February 2004 – April 2005

●Performed routine manufacturing operations for the production of clinical and commercial products

●Performed daily and weekly suite cleanings using spor-klenz and other cleaning aids

●CIP of preparation and hold tanks before start of process

COP of dirty parts using caustic tanks

●Seven day matrix process; responsible for final product dispensing. Through chemical washes and testing PH and conductivity.

●Maintained records and clean room environment to comply with regulatory requirements, GMPs, and SOPs

● Autoclaving of process parts for sterilization.

Manufacturing Operator

Biopure Corporation: Cambridge, MA

March 2002 – November 2003

●Performed routine manufacturing operations in a cleanroom facility and Class 100 rooms

●Performed weigh and dispense of chemicals needed for processs

●Label and packaging of the final product before final release of product.

●Removed bio-waste from facility

● Maintained records and documented work using GMP's

Education: Framingham State College: political science.

Highest completed Natick High School.

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