Control Specialist Quality Controller
Resume:
BHUMICA PATEL
Iselin, NJ *8830
Cell: 848-***-****
****************@*****.***
EDUCATION:
M. S. University of Vadodara Gujarat, India
Bachelor of Science
Graduation: May 2000
WORK EXPERIENCE:
Bristol Myers Squibb Summit, NJ
Manager, QC Microbiology (CAR-T Cell Therapy) August 2022 – Present
• Responsible for supervising and overseeing the activities and personnel in the microbiology group as they perform routine EM (Environmental Monitoring) Sterility, Growth Promotion, EM plate reads, Endotoxin, Mycoplasma, and non-routine microbiological testing and activities to support Aseptic Process Simulations, In-process EM, EM Performance Qualifications, Gowning Qualifications, Aseptic Operator Qualifications and contamination control activities in support of CAR T manufacturing operations.
• Trends data, prepare metrics, reviews documents, reviews procedures, protocols/reports, supports investigations, and works on CAPAs.
• Performs responsibilities independently in accordance with the BMS’s policies, procedures, and state, federal, and local laws and ensures compliance with current Good Manufacturing Procedures (cGMP), USP, EU, and other regulatory guidelines/requirements always.
• Mentor lab personnel as needed.
• Ensure employees assigned to tasks are properly trained.
• Complete performance evaluations and take additional action as needed.
• Support career development of direct reports.
• Foster a positive and inclusive work environment.
• Oversee personnel’s work schedule to ensure all assigned tasks are performed in a timely manner
• Perform data review and additional laboratory activities when needed.
• Ensure laboratories remain in an audit ready state.
• Utilize scientific principles to assist in troubleshooting and problem solving for deviations.
• Serve as author and/or technical reviewer of departmental SOPs and other technical documents.
• Write and review protocols and reports and support special projects. MTF Biologics Edison, NJ
Quality Assurance Team Leader/Supervisor May 2015 – June 2022 Quality Assurance Specialist May 2015 – June 2022
• Gown-in qualified in ISO environments (ISO 4-8) with Aseptic techniques.
• Performs Environmental Monitoring (EM), comp air, water, swab, and nitrogen testing.
• Lead instructional trainer for all new employees within quality and processing departments for aseptic collection of environmental monitoring water and swabs samples.
• Equipment certification and clean room certification review during critical events/shutdowns.
• Perform Secondary reviews of EM data to ensure daily, weekly, and monthly frequencies are met per the SOP, WI, and cGMP.
• Ensure accuracy by identifying deviations, discrepancies, and non-conformances
• Perform QA review of recorded measurements, packaging and labeling documentation, Lab results, monthly metrics & processing and storage documentation for tissue and medical devices
• Analyze rework work orders and ensure the accurate destruction of tissue, if required
• Enter all data into the Quality Data System and transfer Work-In-Process tissue to the appropriate location.
• Reviewer and approver of raw material packets for incoming supplies and raw materials used for aseptic processing and testing under AQL specifications.
• Identify issues with documented processes, analyze data for accuracy, and provide recommendations to improve quality control.
• Trained to assist and generate on nonconformances for QA Technician team.
• Complete necessary actions as needed for nonconformance reports, including investigation report, root cause analysis, corrective and preventative action and implementation of actions
• Collaborator on updates to the SOPs WIs, and Forms to improve QA procedures.
• Controlled room code of conduct mentor to new personnel and Aseptic technique SME.
• Retrieve, reconciles, and ship finished good samples to contract labs under critical temperature conditions. Samples are including, but not limited to sterility, bioburden, transport solution, LAL, water, viable air and surface and finger touch plates.
• Investigate and resolve issues with the internal/external facilities and laboratories regarding receipt of the sample, final reports, or paperwork discrepancies.
• Interact with all departments to organize, review, and analyze all EM data to the release of tissue or medical devices for compliance.
• Assist Quality Engineers and Dermis department with set up of non-viable testing to ensure a successful validation run.
• Generate weekly/monthly schedule for all QA Technicians as part of leadership role, and ensure all tasks are completed within the necessary timeframe.
• Identify deviations, discrepancies, or non-conformances associated with work order. Notify the appropriate individuals, complete the necessary documentation, and ensure the deviations, discrepancies, or non-conformances have been resolved before the tissue or medical device units are released.
• Verify CI, Bio indicator vials and documents.
• Working on multiple projects with internal and external department.
• Managed 10 team members across all shifts, weekdays, and weekends to ensure environmental testing was performed per procedure or post clean room repair, critical incoming materials were inspected in order of priority to meet production needs and discrepancies were resolved quickly.
• Performed root cause analysis and nonconformance investigations, implemented and sustained corrective actions supporting by CAPAs.
• Subject matter Expert for all new tissue form projects provide guidance on process flow and documentation.
• Served as the QA representative on all major projects across QE, PE, R&D, planning & Regulatory.
• Knowledge of cGMP, GLP, FDA, ISO, GCP requirements.
• Software: MS Excel, MS Word, MS Power Point, Spreadsheet, SAP, Batch Master-control, Track wise, LIMS, MES (Manufacturing Executive System), Compliance wire, QDDS, Nautilus, Smart Solve.
• Maintained all training files for personnel.
• Provide oversight of QA shop floor program. Review and approve including in Learning Management Software, Cell-dox and Compliance wire and Summary Reports.
• Ensure manufacturing compliance with applicable procedures and batch records. Making sure that compliance procedures, systems and controls are up-to-date and effective.
• Perform real time review of manufacturing batch records. Confirm that plant audit procedures are properly carried out and assigned work schedules are maintained. Lead relevant program team meetings.
• Monitoring metrics of operational quality and EHS compliance, using these to drive action and mitigation plans to improve compliance and performance.
• Review manufacturing shop floor documentation. Issue production batch records and product labels to Operations.
• Support delivery of training in quality systems and processes.
• Experience reviewing master batch records and/or executing batch records.
• Experience working with and providing assurance of quality in 3rd parties (CMOs / contract manufacturing / contract resource organizations).
• Experience with Deviations, customer and vendor complaint processes, Quality and Technical agreements.
PIM Brands Somerset, NJ
Quality Control Specialist 2015
• Responsible for documentation as followed by GMP and SQF certified.
• Perform Brix (refractometer) and pH analysis (pH meter)
• Perform visual, sponge swabs, and ATP testing after equipment is cleaned and sanitized.
• Release bulk within specification, reject with disposition any product out of specification.
• Perform metal detector test to assure its proper function.
• Perform calibration of pH meter and refractometer.
• Perform organoleptic testing for colors and flavors.
• Approve or reject reworked items.
Accriva Diagnostics (ITC) Edison, NJ
Quality Assurance Specialist and Quality Control Specialist September 2008 – October 2014
• Responsible for the inspection and checking of the weight of all products followed by SOP and record properly.
• Inspecting and checking operation output and measuring its performance as per established parameters.
• Analyzed requirements in connection with products and checking the quality of products and performance.
• Tested the products with variety of mathematical and statistical tools and techniques to ascertain its quality performance, before selling them into the market.
• Perform accurate record of all quality checks and inspection services for reporting, such records facilities decision making at managements level.
• Detected any defects and verifying accuracy and exactness of production to determine modifications.
• Making all final DHR paperwork in computer for finalized production.
• Run all computerized machinery in production filling machine, Lyophilization machine with insert
–out materials.
• Lead person for production in absence of supervisor.
• Monitoring all alarm system for pharmaceutical.
• Handle the biohazard materials.
• Utilized sterile technique including cleaning, disinfecting and sterilization of instruments and supplies.
• Operating machinery such as, vision, combo, cuvettes manufacturing.
• Performs laboratory microbiological, physical, and analytical testing as designated.
• Monitoring temperatures of laboratory freezers, incubators, and refrigerators, etc. Additional Skills:
• Online portals such as QDDS, Nautilus, CELabs, Smart Solve, NAMSA, APPTEC, NELSON, VRL.
• SAP, MS Excel, MS Word, MS Power Point, Spreadsheet, Batch Master-control, Track wise, LIMS, MES (Manufacturing Executive System), Compliance wire, QDDS, Nautilus, Smart Solve. SUMMARY /SKILLS:
• Over 20 years working experience in the pharmaceutical/medical device Industry.
• Identify deviations, discrepancies, or non-conformances associated with work order. Notify the appropriate individuals, complete the necessary documentation, and ensure the deviations, discrepancies, or non-conformances have been resolved before the tissue or medical device units are released.
• Managed 10 team members across all shifts, weekdays, and weekends to ensure environmental testing was performed per procedure or post clean room repair, critical incoming materials were inspected in order of priority to meet production needs and discrepancies were resolved quickly.
• Performed root cause analysis and nonconformance investigations, implemented and sustained corrective actions supporting by CAPAs.
• Subject matter Expert for all new tissue form projects provide guidance on process flow and documentation.
• Served as the QA representative on all major projects across QE, PE, R&D, planning & Regulatory.
• Familiar with clean room procedures and medical equipment.
• Knowledge of Aseptic techniques.
• Ability to train groups on Aseptic technique, EM, water, and swab testing.
• Perform secondary review for daily, weekly, and monthly EM requirements.
• Knowledge of multiple tissue types.
• Work with potential biological hazardous material.
• Knowledge of measuring equipment, micrometers, calipers, gauges.
• Quality Controller in Production followed by SOP and GMP, inspect and release good product for pharmaceutical product.
• Inspecting and checking operation output, analyzed requirements in connection with production quality and performance, detected any defects and verifying accuracy for release product.
• Quality Assurance in pharmaceutical production using microscope measuring parameters, weight check for all products, accurate record of all quality checks and inspection services for reporting.
• Handling blood, body fluids, human skin samples.
• Run computerized machinery such as lyophilization Machine for Pharmaceutical manufacturing.
• Filling medicine in machinery and able to run and supervise.
• Able to make reagent in lab for production.
• Basic knowledge of computers, Word, Excel, Power point.
• Making all DHR final paperwork for release products.
• Operate machinery such as: vision, filling machine with caliper, combo machine and computerized medical device.
• Perform Brix (refractometer) and pH analysis (pH meter)
• Perform visual, sponge swabs, and ATP testing after equipment is cleaned and sanitized.
• Release bulk within specification, reject with disposition any product out of specification.
• Perform metal detector test to assure its proper function.
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