Aseptic Supervisor Biologic Processing Tech III Resume Example Company Name

ASEPTIC SUPERVISOR BIOLOGIC PROCESSING TECH III

Professional Summary

Experienced supervising, critically problem solving skills essential training, and providing mentorship to groups of 05-40+ quality/production technicians across several shifts. Ample experience following and meeting tight production schedules following all regulatory guidelines from the FDA, EMA, ICH,and other international entities, experienced performing quality control activities and conducting testing in a laboratory environment and manufacturing environment, additionally, versed with a number of immunology, Biotechnology, Chemistry, Cell Culture, electrophoretic, and microbiology I/II, Applied Microbiology techniques with Labs.

Skills

Immunology: Enzyme-linked immunosorbent assays (ELISA), immunofluorescence assay (IFA), Single Radial Immunodiffusion Bioassay (SRID)

Cell Culture: Aseptic techniques, transfection / transformation, cytotoxicity Bioassay's, animal and plant tissue culture, pH meter, microscope, centrifuges, aseptic Multichannel micropipetting, welders, sealers, cell count under sterile techniques, plating, passaging, cellular incubation, re-cultured established cancer cell lines, freezing cells, media / reagent preparation, dilution factors.

Electrophoretic: SDS polyacrylamide gel electrophoresis (SDS-PAGE), Western blot, Southern hybridization).

Chemistry: Wet Labs, Prepared chemicals and agars/medium for undergraduate labs; Immunology and Cell culture groups of students.

Using autoclave to dispose of biohazard material, as well as sterilize media and glassware. Extensive training in laboratory BSL-1, BSL-2, BSL-3.

Microbiology: Streak to isolate, gram stain, cultures of different organisms Independently monitored, collected, evaluated and reported all data on routine & non-routine environmental monitoring, gram staining, spore, and preparation of buffers, media, pour plates, plating antibiotic-sensitivity testing, Worked with Mac Conkey's, Tryptic Soy Agar, Mannitol Salt Agar, Blood Agar, aseptically prep/pour media and recorded all data pertaining to incubation time and results.

Compliance: Change Controls, Control documents, Log books, change control, Resolutions of Out of Specification (OOS) ,and Corrective actions and preventive actions (CAPA).

Computer: Microsoft Word, Excel, PowerPoint, Trackwise. SAP, SOP, LIMS, Clinical Laboratory Instrument plus calibrations, IMMUlab, SCORE, Electronic Batch Records (EBR), Master Data in Manufacturing Execution System (MES) and Distributed Control System (DCS),

Languages: Bilingual ( main English - secondary Spanish)

Work History

Aseptic Supervisor Biologic Processing Tech III, 12/2015 to 03/2020
Company Name – City, State

Performed in a compliant aseptic clean lab environment routine processes related to formulation, sampling, filling,capping, and sterile processing for Kogenate and Kovaltry.
Liaise with Engineering Dept., Maintenance dept., Quality Assurance, Quality Control ongoing process.
Health, Safety, and Environment (HSE) complete compliance through monthly safety inspections with follow up which include any action items.
Managed product quality to guarantee compliance with quality policies, SOP procedures, and systems.
Supervised/trained new and existing employees in sterile aseptic SOP procedure, protocols and gown qualifications to perform activities and interventions in Class A/B areas, Facility is 24/7 schedule with several shifts.
Met aggressive production and safety goals.
Preparation of buffers and other reagents, solutions, calibration and maintenance of laboratory equipment.
Data interpretation and providing data summaries for method development, validation, and testing.
Created and revised SOPs, assay procedures, and reports.
Ensured processing sampling for lab, re-qualifications, maintenance, and calibration on all equipment in restricted A-F areas.
Monitored work environment Cleanroom area in accordance with FDA regulations in compliance with Current Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Automated Laboratory Practices (GALP), Good Weighing Practices (GWP) requirements and safety inspections, including development and completion of corrective and preventive actions (CAPA) and continuous daily update in logbooks.
Followed cGMP SOP's for management of stability, standards and control programs, Distributed Control System (DCS), Master Data in Manufacturing Execution System (MES), Electronic Batch Record( EBR), .
Maintained laboratories in safe compliant FDA regulatory state; tracked cycle counts and inventories in SAP, LIMS, Trackwise.
Kept operations in compliance with company, safety and legal requirements.
Exceeded goals through effective task prioritization and great work ethic.
Helped managers make accurate decisions by tracking deviations from production targets with daily logs.
Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
Completed frequent inspections to identify and resolve problems affecting performance.
Took samples every set time to compare quality with specifications.
Resolved conflicts and negotiated mutually beneficial agreements between parties.

Validation and Quality Control Technician (SRID), 06/2014 to 04/2015
Company Name – City, State

Performed testing to meet demands of batch release, production, validation, independent demand, and stability programs. Followed testing schedule defined by lab management. Validated SRID (Single Radial Immunodiffusion) test gels for batch release potency; performed staining, pressing, scanning, and documentation; stored all cell cultures, and performed script reading of culture.
Ensured product integrity by pulling samples, placing work orders, performing a visual inspection of samples, preparing samples for testing, and conducting validation of instruments and reagents.
Conducted inspection, testing, and release of raw materials, strictly adhering FDA and CBER regulations to Standard Operating Procedures (SOPs), SWIs, CBER, Good Laboratory Practices (GLP), and Current Good Manufacturing Procedures (cGMPs) material specifications.
Contributed to the development and maintenance of validation quality management system, which involved master computerized systems list, master validation schedule, and validation department SOPs. Training all laboratory and microbiology employees. Sterile Aseptic qualifications at 100% and micromanipulations with cell culture Cancer Cell line, PCR, Influenza, microbiology, Dengue, and Yellow fever.
Managed environmental plates monitoring of aseptic manufacturing operations in Grade A, B, and D clean room environments and other classified areas. Collected and evaluated all pertaining study data.
Troubleshoot sample discrepancies; completed required paperwork, change controls.
Maintained laboratories in a safe, compliant state; tracked cycle counts, confirmations, and inventories in SAP, LIMS, and Trackwise.
Ensured 100% compliance with ISOtrain, LabWare, and Immulab. Performing Bioassay testing, updating procedures, and protocols also conducting training assessments and verifications of these subjects.
Directed projects; scheduled resources, trained employees, completed work orders and provided status reports to management.
Managed +QDCI safety/quality deliverables cost involvement whiteboard. Daily team group meetings
Liased with the team tasked with the testing batch release of active pharmaceutical ingredients (API). Validated API batch release product.
Earned certifications in aseptic techniques, pipetting techniques, records and documentation, and binding of all departmental raw data for batch release.

Laboratory Assistant, Cancer Cell Culture Lab., 06/2013 to 05/2014
Company Name – City, State

Supervised and managed multi-level groups of 05-40 personal, while preforming training of aseptic techniques/prepping for experiments. Performed multichannel micropipette, standard plate count, plate incubation and direct microscopic cellular count.
Measured cellular activity and colony-forming units (CFU). Cultured tissues and bacterial and viral isolates.
Maintained all Aseptic techniques/procedures, Lab notebook, protocols for laboratory during testing/non-testing.
Assisted students with procedures and experiments and aseptic techniques.
Maintained safety and identified improvement opportunities in safety and compliance.
Prepared chemicals and agars/medium for undergraduate cell culture\immunology, chemistry.
Inventoried microbiology media and chemistry/organic chemistry chemicals.
Familiar with using an autoclave to dispose of biohazard material, as well as sterilize media and glassware.
Conducted trial experiment on biofilms for allied health microbiology lab.
Created indicators, pH buffers, unknown concentrations of stock solutions for organic chemistry experiments.

Immunology Lab Coordinator, 06/2013 to 05/2014
Company Name – City, State

Prepped lessons\equipment for specific electrophoretic techniques including SDS-PAGE and ELISA.
Maintained lab notebooks, performed sterile housekeeping, and managed all aspects of immunology/cell culture lab.
Conducted DNA fingerprinting workshops for local high school students.
Set up multiple lab experiments for class; prepared equipment, reagents, assays, buffers and media for class experiments. Maintained supplies for lab and made weekly verbal/lab note reports to "Director of the Biotechnology of East Stroudsburg University".
Conducted extensive initial training for instructors, student assistants and new employees to cover safety hazards of each laboratory.
Conducted training for student for multichannel micro-pipette and familiarity with all Laboratory equipment's, safety guidelines and all performing analysis testing.
Qualified students, instructors and new employees to handle microorganisms safely and adhere to all SOP protocols..

Education

Bachelor of Science: Biotechnology, 2014
EAST STROUDSBURG UNIVERSITY - City, State

Associate of Science: 2009
PASSAIC COMMUNITY COLLEGE - City, State

Resume Overview

School Attended

EAST STROUDSBURG UNIVERSITY
PASSAIC COMMUNITY COLLEGE

Job Titles Held:

Aseptic Supervisor Biologic Processing Tech III
Validation and Quality Control Technician (SRID)
Laboratory Assistant, Cancer Cell Culture Lab.
Immunology Lab Coordinator

Degrees

Bachelor of Science : Biotechnology , 2014
Associate of Science : 2009

Aseptic Supervisor Biologic Processing Tech III Resume Example

Resume Score: 80%

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