STEVEN D. LEVIN

**** ****** ****

PHILADELPHIA, PA. 19115-4518

215-***-****(C)

ad4ftk@r.postjobfree.com

http://www.linkedin.com/in/stevendavidlevin

OBJECTIVE

A challenging career with a growth-oriented pharmaceutical / chemical firm in the fields of quality control/quality assurance and analytical/microbiological laboratory operations

EXPERIENCE

Sample Coordinator I – Resalion – 09/23 – 03/24 – Malvern, Pennsylvania

* Received and accessioned samples in LIMS system

* Pulled and organized samples for analysis

* Maintained traceability and security of samples within LIMS and freezers

* Learned freezer and other equipment maintenance procedures

* Learned sample discrepancy resolution and client communication processes

* Recorded tasks in accordance with Good Documentation Practices (GDP)

* Learned and applied regulatory requirements; HIPAA, GLP, GCP, 21CFR Part 11

* Followed applicable SOPs and procedural documents

* Ensured lab area is clean and inspection ready at all times

* Performed other tasks as assigned

Laboratory Facilities Support Specialist III (Senior) - Ubertal at Merck – 07/22 – 09/22 – West Point, Pennsylvania

*Primary functional responsibility was the execution of processing suite maintenance within the policies and procedures of the department, division, company and other applicable mandates while maintaining the highest level of proficiency in the responsibilities required of cGMP processing areas

*Fostered a customer service attitude within and among facility and equipment personnel

*Ensured work was documented in compliance with the ALCOA principles of data integrity, cGMPs, GLPs, and departmental procedures

*Completed assigned suite maintenance activities within the timeframes required by departmental and site procedures

*Supported material and facility management activities as required

*Gowned to meet cGMP or safety requirements (e.g., aseptic gowning or live virus/BSL-2 gowning)

*Demonstrated interpersonal skills including flexibility, collaboration, inclusion skills and ability to work in a team environment

*Demonstrated critical thinking skills and problem solving ability

*Honed strong written and verbal communication skills

Laboratory Technician I – Kelly Scientific Services at Eurofins Abraxis – 10/21 – 06/22 – Warminster, Pennsylvania

*Complied with all relevant SOPs, Work Instructions, Rules, Regulations and Manuals

*Managed batch records

*Prepared buffers, reagents and solutions

*Performed ELISA testing in both manual and automated modes

*Filled, sealed and labelled bottles and vials

*Assembled kits for both ELISA and lateral flow

*Manufactured microtiter plates

*Purified antibodies

*Operated and maintained the Oyster Bay Plate Coating Machine and Printer

*Operated freeze-dryers and the lyophilizer

Laboratory Facilities Support Specialist II – Ubertal at Merck – 10/19 – 06/21 – West Point, Pennsylvania

*Performed all aspects of laboratory decommissioning support services including hazardous materials management, instrument inventory and decontamination, shipping and documentation. Collected and maintained inventory of liquid hazardous materials waste and prepared for disposal through authorized waste hauler

*Followed procedures as dictated in the Chemical Hygiene Plan

*Performed functions, within training guidelines and standards, with hazardous/non-hazardous biological waste to include but not limited to labeling, sorting, transporting, and storing at designated areas. Performed general maintenance tasks on equipment and facilities. Worked with repair contractors and landlord to explain malfunctions of facilities and equipment

*Participated in on-call rotation with other staff to provide after-hours emergency response

*Kept current with all site training requirements including but not limited to: RCRA Hazardous Waste Handling, HAZWOPER-40, HAZCOM, SPCC, DOT, biosafety and bio waste handling, site SOPs, and any other training required by Merck

*Inspected fire life safety equipment including fire extinguishers, eye wash stations, emergency showers, and emergency lighting

*Performed radioactive materials wipe testing, waste consolidation and shipping duties

*Maintained facilities regulatory permit files and provided testing / samples as required

*Worked in collaboration with Global Safety and Environmental staff to assure compliance and safety audit readiness

Laboratory Technician – Randstad at Menarini Silicon Bio Systems – 11/18 – 06/19 – Huntingdon Valley, Pennsylvania

*GMP laboratory equipment maintenance activities - cleaning, descaling, detergent dosage determination and stainless steel polishing of glassware washer, replacement of paper tape and printer cartridges for balance printers, sealing, bagging, expiration dating and restocking of clean glassware and equipment, flushing of emergency eyewashes, monitoring temperature and humidity in facility refrigerators, freezers, cold rooms, incubators and suites, changing out chart recorder sheets on a weekly basis

*Filling & Kitting of test kits for shipment

*Review of completed batch records for manufacturing

*Performed routine lab maintenance activities - calibration of balances and floor scales, flushing of reverse osmosis de-ionized water ports, removal of bio-hazardous waste, washing of glassware and tools, periodic surface cleaning of bench tops and tabletops, restocking of laboratory drawers, replacement of sticky floor mats

* Use of various electronic documentation systems for reagent production and cell culture activities

* Document creation and or revision as needed

* Daily (typically) equipment washing for Quality Control and Reagent Manufacturing

* Prepared and monitored the iso-ascorbic acid bath for glassware cleaning

* Maintained chemical and materiel inventory

Laboratory Technician – Aerotek at Datwyler – 05/18 – 08/18 – Pennsauken, New Jersey

* Performed analytical chemistry tests on rubber production samples and raw materials – hardness, color, density, volatile sulfides, fly ash, infrared spectrophotometry, ultraviolet spectrophotometry, turbidity, moisture content, reducing substances, and swell test

* Packaged, released and quarantined batches based upon test results

* Operated, calibrated and maintained hardness tester, color reference sheets, density balance, autoclave, convection oven, Perkin-Elmer FTIR spectrophotometer, Perkin-Elmer UV spectrophotometer, turbidometer, moisture apparatus, pH meter

* Updated and maintained equipment logbooks

Sampling & Data Management Technician – Mindlance at Bristol-Myers Squibb – 01/17 – 07/17 – Hopewell / Pennington, New Jersey

* Responsible for sample submission/distribution/tracking activities, sample inventory and maintaining accurate and complete records for samples and other GLP/GMP compliance activities as assigned

* Processed incoming and outgoing samples, for release, re-assay, stability, validation and development testing including reagents and reference materials to support clinical development including GLP/GMP sample administration activities

* Administration of sample tracking activities and sample documentation for receipts, shipping and inventory of GLP/GMP samples and reference standards

* Maintained shipping documentation for all samples for both incoming and outgoing shipments

* Supported department analysts by providing sample and reference standard retrievals and inventory reports utilizing Freezer Works

* Released samples for testing using departmental notification procedures

* Submitted and log in samples in PDLIMS and Freezer Works for such materials as:

-GMP Clinical release and re-assay and GLP study support

-Long Term Stability Studies (LTSS)

-IND, IMP, and BLA submissions

-Analytical Method Development

-Validation of Analytical Methods

* Adhered to cGMP/GLP, good documentation practices, departmental procedures and safety requirements, maintaining control of incoming and outgoing samples and other materials for validation work, development projects and outsourced testing

* Provided support to personnel in generating and extracting sample information and documentation

* Documented relevant activities in equipment logbooks that includes equipment performance, review of calibration, maintenance and inventory of all freezers and refrigerators used to store materials

* Clearly and accurately documented work reflecting movement, handling and aliquotting of samples on worksheets and logbooks. Maintained records to ensure accurate inventory and traceability

* Trained other department personnel in sample management activities

* Assisted in reviewing and revising SOPs, Forms, Templates, WIs, pertaining to job activities

* Supported investigations as required

* Individual had GMP responsibilities/performed GMP tasks

* Individual had GLP responsibilities/performed GLP tasks

Maintenance Management Analyst – United States Air Force/Air National Guard/Delaware Air National Guard – 05/16 – 09/16 – New Castle, Delaware

* Monitored, collected, assembled, and audited data for reports and briefings

* Initiated special studies and investigations and performed statistical analysis

* Reported findings to managers with recommendations

* Informed managers of significant factors affecting the mission

* Managed and operated maintenance management information systems (MIS), and performed functional system administrator (FSA) duties

Quality Assurance Sampling and Inspection Technician II - McNeil Consumer Healthcare/Johnson & Johnson - 06/13 – 12/15 – Fort Washington, Pennsylvania

*Provided testing, sampling and technical support for the Quality Assurance department in the logistics area

*Sampled and tested chemical components, bulk materials, containers, closures, labeling, & packaging materials

*Provided training to other Sampling and Inspection employees

*Provided support to audits and audit observation resolution

*Prepared and delivered samples to the laboratory for testing

*Prepared samples for long term storage in the Retain Room

*Attended webinars/seminars/classroom training as required

*Performed other related duties as required

*Served as the Subject Matter Expert in the Sampling and Inspection department

Quality Assurance Retain Room Technician II – McNeil Consumer Healthcare/Johnson & Johnson - 10/12 – 06/13 - Fort Washington, Pennsylvania

*Logged production, external manufacturing, customer complaint, recall samples and raw material samples into LIMS and Retain Room logbooks

*Completed annual visual inspection on selected samples stored in Retain Room

*Completed other inspections on samples as required

*Completed annual inventory on all samples stored in Retain Room

*Completed other inventories as required

*Prepared expired samples for removal from Retain Room and destruction

*Maintained pseudoephedrine-containing products and raw material samples under lock and key

*Prepared pseudoephedrine-containing products and pseudoephedrine raw material samples for removal from Retain Room and destruction via certified contractor

*Maintained Honeywell DPR 180 Temperature/Humidity Chart Recorder

*Responded to any and all temperature/humidity excursions occurring in the Retain Room

Quality Control Laboratory Technician II – McNeil Consumer Healthcare/Johnson & Johnson – 03/12 – 10/12 – Fort Washington, Pennsylvania - See all Kelly and all McNeil duties below -

Research & Development Laboratory Technician II – McNeil Consumer Healthcare/Johnson & Johnson – 06/11 – 03/12 – Fort Washington, Pennsylvania - See all Kelly duties and all additional McNeil duties below - Additional duties as a McNeil Consumer Healthcare R&D

Laboratory Technician II –

*Maintained Stability Chamber inventory

*Imported Method documents from other J&J sites via CONNECT system

*Assigned equipment logbook to each DR bath in Research C Laboratory

*Trained on High Performance Liquid Chromatographs

*Attended meetings/webinars/classroom training sessions on various R & D topics

Quality Control Laboratory Technician II – McNeil Consumer Healthcare/Johnson & Johnson - 07/02 – 06/11 – Fort Washington, Pennsylvania - See all Kelly duties below - Additional duties as a McNeil Consumer Healthcare Quality Control Laboratory Technician II –

*Monitored temperature chart recorders for the Dry Chemical Storage room refrigerator and the Wet Laboratory refrigerator/freezer and changed out/file data sheets weekly

*Assisted Sampling and Inspection with issuance of packaging materials to include labels (controlled item) to the production floor

*Performed daily calibration of laboratory balances

*Participated in monthly site Fire Brigade training sessions

*Answered McNeil site fire alarms and EMS alarms

*Performed monthly operations check of emergency eyewashes and showers

Quality Control Laboratory Technician I - Kelly Technical Services at McNeil Consumer Healthcare/Johnson & Johnson - 04/99 – 07/02 - Fort Washington, Pennsylvania

*Performed analytical chemistry tests on production samples, stability samples and components – pH, viscosity, density, deliverable volume, re-dispersability, dissolution, disintegration, infrared spectroscopy, ultraviolet spectroscopy, and de - foaming tests

* Operated, calibrated and maintained Perkin-Elmer UV spectrophotometers as a part of dissolution testing performed on samples pulled from Tylenol solid dose production batches

* Entered test results onto LIMS worksheets and into LIMS computer program.

* Reported OOS and OOT results to senior staff

* Operated, calibrated and maintained Perkin-Elmer FTIR spectrophotometers as a part of IR testing performed on samples pulled from Tylenol and Motrin solid dose and liquid dose production batches

* Entered test results onto LIMS worksheets and into LIMS computer program

*Reported OOS and OOT results to senior staff

* Operated, calibrated and maintained Perkin-Elmer FTIR spectrophotometers as a part of IR testing performed on samples pulled from APIs, flavors, colors, starches, and gelatins

*Entered test results onto LIMS worksheets and into LIMS computer program

*Reported OOS and OOT results to senior staff.

*Received production and components samples from Fort Washington facility, other McNeil/J&J sites, and outside contractors and vendors and logged them into the Laboratory Information Management System computer database

*Ordered, received, and stocked reagents, equipment parts, and general laboratory supplies – updated quarterly the inventory of dry chemicals, solvents, liquid chromatograph / gas chromatograph columns and general laboratory supplies

*Performed daily/weekly/quarterly sanitization procedure on laboratory de - ionized water ports

*Conducted monthly inventory of expired reagents, solutions, and solvents - disposed of same - arranged for professional disposal when necessary

*Executed daily sweep of wet laboratory, instrument laboratory, and sample bin room to remove production, stability, and component samples that had completed testing

*Weighed out solid dose production and stability samples for analysts

*Assisted senior staff with any task

EDUCATION

Senior at Philadelphia University – Major – Biology

Bucks County Community College, Newtown, Pennsylvania – Associate of Arts Degree in Biology - May 1996

MILITARY SERVICE

United States Air Force Air National Guard – May 2007 – May 2017

United States Air Force Reserves – March 1988 – May 2007

United States Air Force Active Duty – March 1981 – March 1988

PROFESSIONAL ORGANIZATIONS

American Chemical Society – Member, 1995 - present

American Institute of Biological Sciences – Member, 1998 – present

American Society of Microbiology – Member, 1998 – present

Air Force Association – Member, 1999 – present

Air Force Sergeants Association – Member, 1999 - present

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