Medical Manager

Brian McKnight Hackensack, New Jersey #201-***-**** (Home) *****.***********@*****.***

** ***** ** **** ********** in production, quality inspection, inventory & pharmaceuticals education & skills at bottom

Worked with sterile non sterile, medical devices, oral chemicals & powders, over the counter solid dosage medications

Packaged implants, inhalants, asthma, malaria and other various medications, verifying correct labeling of product

Handle various projects for medical device inspection for engineering team scan bar coded items into the inventory system

Contract Assignments 2009 – 2018

Production Operator Inspector – Instrumentation Laboratory 09/2018 – 11/2018

Orangeburg, NY

Complete all work orders for assembly of medical device machinery, work on assembly line and perform multiple inspections

Work in cGMP manufacturing area, label inspection fill out batch record and report logs, keep work areas clean of contamination

Wear proper PPE, also assist line personnel work with fluids in the Critical Care Department, follow all company SOP’s

Generate production reports on word documents & input data on excel spreadsheets, use of company email system

Production Technician QA/QC – Natural Flavors, Inc. 02/2018 – 06/2018

Port Newark, NJ

Work in the lab & warehouse gathering samples of company oral food flavoring liquids to send to new company owners.

Assist in the warehouse of incoming materials take samples to QA Dept. for analysis, locate chemicals and put items released

Back into stock, label products check lot codes & item numbers, used PPE, gowning, nitrile gloves, steel toe shoes, hairnet and

Lab coat, report errors on master list to the QA Director for correction, pack & ship out items to new company owners

Make sure all products are compliant to SOP’s and validate correct name on labels for QA lab personnel

Input sample information on excel spreadsheets for manager to view, worked on various projects for the QA Director

Automotive Safety Inspector – Foreign Auto Preparation Service/F.A.P.S. 12/2017

Port Newark, NJ

Inspect vehicle seat belts, brake lines, transmission shifter & body prior to being shipped out of the country

Make sure inspections are compliant to specifications bring to attention of supervisor to validate findings

This location I worked out of was Port Newark, NJ our team inspected over 6000 vehicles for these safety issues

Assisted in projects for finding vehicles that needed rework or that have safety issues that have to be inspected

Blending Operator – Nature’s Bounty/Solgar, Inc. 07/2017 – 09/2017

Leonia, NJ

Responsible for activities related to blending the product per formula instructions, also follow all SOP’s & cGMP’s

Operate all machines match all labels with batch records, physically load & unload blending machines, monitor blending

Operation periodically report any abnormal conditions to the manager, follow all safety rules & regulations

Perform major cleaning of machinery & equipment on a daily basis with industrial cleaning solvents

Use of many powders and oral chemicals liquids mixing to manufacture popular brand vitamins

Quality/ Mechanical Inspector – Zimmer-Biomet Inc. 08/2016 – 01/2017

Parsippany, NJ

Perform geometric dimensioning, tolerancing & mechanical inspection of medical devices & prepare chemistry report information On knees, hips, shoulders, instruments using Instron Bluehill versions 2 & 3 software, machine #5567 testing devices for tensil strength make certain all parts are within tolerance per blue print perform line clearance, GMP & CAPA reporting if necessary Inspection of prototypes, clinical trials & sample products, final inspection performed 1st article inspection performed, AQL sampling & assist QA personnel in writing updates on inspection protocol per SOP & if materials are place on hold status make sure all samples are compliant to print double check with supervisor to validate questionable material measurements, worked on various projects for the engineers perform inspection of various prototypes of medical devices for the QC Dept. CFR 820 parts 210, 211

Quality/Inventory Coordinator – ZT Systems, Inc. 03/2016 – 04/2016

Secaucus, NJ

Inspected parts for computer servers to build racks, issue part orders to factory personnel keep track of SKU’s

Key information received from SKU items into excel spreadsheet, inform management of racks manufactured

Assist QA personnel for identifying non conformance material write CAPA report if necessary, AQL sampling

Input line items on excel spreadsheets & generate reports for management

Pharmaceutical Packaging Technician – Halo Pharmaceuticals, Inc. 01/2016

Whippany, NJ

Inspection of labels, bring product to line such as caps, bottles, label reel, clear line jams perform final

Inspection of product before it gets packed & placed in the warehouse, identify cause of line stoppage

Packaging of creams & lotions brought to the line make sure they are compliant with the SOP’s

Feeder Associate/Trailer Inspector – United Parcel Service 10/2014 – 12/2015

Saddle Brook, NJ

Inspect 160 trailers daily for lost packages, radio dispatch have packages scanned in the system to notify customers Found 696 packages for UPS customers left in trailers & 11 LOADS that were not inbounded or showing on property. I had 5 supervisors & the manager say I was the best Yard Checker they had in many years working for them also given full time hours

Medical Device Technician – Pentax Medical, Inc. 04/2014 – 10/2014

Montvale, NJ

Recently taken course on EHS, Environmental Health & Safety & chemicals storage

Inspect & sterilize Endoscopes, Bronchoscopes & medical devices per SOP specifications

Use of hydrometer, pressure pump, water test & check sinks for proper chemical levels performed leak test

Train new temporary personnel monitored aseptic tanks operate autoclave sinks for products to be sterilized

At shifts end drain all sinks & autoclaves, follow FDA code of regulations 21 CFR 820 & Parts 210 & 211

Development Packaging Technician – Novartis Pharmaceuticals, Inc. 06/2012 – 02/2013

Suffern, NY

Inspection of labels, operate various machines on the packaging line develop & improve labeling on

product medications bottles, work with team for better process controls, identify cause of machine

break downs, try to increase production times, assist in new design of packaging labels per SOP’s

follow code of FDA regulations 21 CFR 820 & Parts 210 & 211 take corrective action write CAPA reports

assist supervisor for inventory of product materials, assist with cost & budget of materials being used

Make sure all labels and materials are compliant with recipe for product run to pass validation

Assist in packaging of asthma nasal spray & other inhalants also bubble blister pack medications

Packaging Operator – Novartis Pharmaceuticals, Inc. 07/2011 – 02/2012

Suffern, NY

Operated unscrambler, desiccant, filler, capper, sealer, retorquer, labeler & robotic packer bundler

Perform visual inspection of clinical trial & sample lots, use of magnifying glass for visual aid of product

Inspected tablets, capsules, bubble blister packages for defects, place non conforming tablets in reject bin

Perform major cleaning of packaging line machines with alcohol and other chemicals, inspect for left over

Tablets in all areas of the machines using flashlights, disassemble filler, manually load filler hopper with

Various tablets, capsules & various medications per recipe for next run, login all information from major

Cleaning into batch history record files, inspected product samples from the line while it is being run

Work 6 different production lines, continue to inspect labels on bottles & boxes, lock out/tag out machine

Ensured compliance with OSHA, ERP, system, GMP’s, MSDS & perform preventative maintenance of the line

Take corrective action write CAPA report if necessary per company’s SOP’s answer auditors inquiries Assist in solid dosage compression cell in the manufacturing of the tablets, assist with machine disassembly

Set up & run machine to package high blood pressure medication then manually package oral liquids

Product Tester – Playtex, Inc. Personal Care Division 01/2011 – 04/2011

Allendale, NJ

Performed quality inspection on baby products packaged finished products checked for bill of materials (BOM)

Inspect outer plastic packaging for safety and strength testing final inspection of packaging labels

Quality Control Inspector – Samsung, Inc. 10/2010 – 12/2010

Perth Amboy, NJ

Performed inspection of televisions, washing machines for damage, repacked goods for shipment

Checked outside box for weather related damage during storage period prior to delivery to retail stores

Packer – Net-A-Porter.com, LLC 07/2010 – 10/2010

Mahwah, NJ

Packed & inspected womens luxury clothing & accessories for shipment, perform label checks for designer

Merchandise, assist in customer returns area tag items in need of repair, unload trucks receive deliveries

Notify supervisor of damaged or soiled clothing then perform final inspection before shipping items

Production Technician – Sigma-Netics, Inc. 05/2010 – 07/2010

Riverdale, NJ

Perform mechanical inspections of incoming merchandise, assemble hydraulic & electrical components for pumps

Work to company engineering drawings per SOP’s, perform final inspection of finished products, soldering rework

Clean Room Technician/Packaging Machine Operator – Stryker Orthopaedics, Inc.

Mahwah, NJ 08/2009 – 04/2010

Worked with hazardous chemicals, mechanical inspection of medical devices, knees, hips, shoulders & custom devices

Taken weekly E3 quality test, read MSDS, update batch history record travel tickets sign off on routers

Sterilize products in autoclaves prior to final packaging area, use of latex gloves, gowns, safety shoes, glasses

Hairnets, beard & mustache cover, face shield & hearing protection, perform bi weekly maintenance on

Machines changed filters, empty tanks of chemicals, log rejected items on CAPA report review

Work safely per OSHA & GMP guidelines, lock out/tag out machines prior to shifts end

Worked with EHS personnel, walk through facility looking for safety issues or concerns

Assist in temperature controlled clean room packaging medical devices & instruments

Permanent Job Work Experience in Accounting Details on another resume

Affiliated Computer Services, Inc. – Accounts Payable Specialist Teaneck, New Jersey

12/1997 – 01/2007

Permanent Job Work Experience in Pharmaceutical Industry

Quality Control Supervisor 3rd Shift – General Foam Corp. East Rutherford, New Jersey

02/1996 – 08/1996

Inspect foam thickness, color & quality per SOP’s train workers on safety related machine operating issues

Assist workers in setting up machines for production runs, use of color charts & measuring tools to insure

Quality merchandise is being manufactured, write up production and performance reports on personnel, resolve

Work related issues affecting production, assist quality manager with budget, labor hours for the department

Inventory Controller/Trauma Line – 3M Corp./Kirshner Medical Fair Lawn, New Jersey

05/1980 – 06/1985

Evaluated inventory on hand, instituted a material requirements plan (MRP) to control inventory levels

Reconciled computerized spread sheet inventories with actual physical inventory counts using excel

Reconciled raw material inventories, LVM stainless steel, cobalt chrome, bone screws, titanium, plastics

Acetabular hips, knees, shoulder cups, contacted vendors for best prices arrange for delivery through

Purchasing department, expedited slow moving & hot items via work in process, manage 100+ items

& their sub assemblies, investigate all material shortage problems, correct & take preventive action

Call for meetings with supervisors & production personnel to find out status of production, assist manager

With budget expense calculations and cost of goods being ordered, issue shop tickets to production floor

Master Hand Finisher – Kirschner Medical/Biomet Corp. Fair Lawn, New Jersey

06/1985 – 09/1995

Master hand finishing of all orthopedic & special order medical devices the company manufactures per

Perform mechanical inspections of all medical devices, before going back out to the production floor

Engineering drawings SOP’s, keep up with production rates goals for the day, train & assist new workers

On the manufacturing & finishing of products (medical devices), assist in foundry department use of cut off

Saw for the castings in foundry, received cross training in OSHA, packaging, quality control/inspection,

Foundry, shipping & receiving and polishing departments, mix batches ingredients together to form new

Materials for castings, check oven temperature, check mixer, pour liquid metal into molds, assist supervisor

Technical Skills & Education

Blue Print reading, Quality Inspection/Supervision use of gauges, micrometers, ring & pin gauges & caliper

Operate touch screen computerized packaging machinery, manually operate robot with joy stick, part of safety team (EHS)

Use of accounting software Oracle & SAP, Knowledge of FDA code of regulations 21 CFR 820 & Parts 210, 211 knowledge of

Inspecting medical devices & over the counter solid dosage products and various other asthma inhalant medications

Hackensack High School, Hackensack, New Jersey – Graduated Received Diploma

Fairleigh Dickinson University Accounting Major, Teaneck, NJ – 36 Accounting Credits

Worldwide Educational Services Business School, Computerized Bookkeeping - Certificate Received Hackensack, NJ

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