Quality Assurance Supply Chain

Brian McKnight

Hackensack, New Jersey ***** #201-***-**** (Landline) *****.***********@*****.***

** ***** **** ********** ** mfg. Operations, QA/QC medical device inspection, aseptic cleaning, labeling, 3 years as Supervisor

Packaging projects, use of various packaging materials, washing bottles, plastics, glass, syringes, buffer & media solution prep

Pilot plant worker shipping & logistics, hazmat experience handling hazardous chemicals, operate autoclave, sterilization of parts

Clean room Gowning, PPE, Bioreator machines, GXP, cGMP & SOP experience, worked with regulatory FDA & Quality assurance

MRP Inventory Control, cutoff castings in foundry, CAPA, Instron measuring, safety meetings, shop floor, review batch records

Was a compassionate caregiver for 5 years, cooking, cleaning, encouragement, physical therapy, giving tender loving care

Fully vaccinated received 5th covid19 shot on 10/15/2024, flu shot on 12/2024 also worked in clean rooms A thru D grade levels

Technical Skills & Education

Assemble clean & sanitize production equipment, Supervision of 7 employees, worked in purchasing, supply chain, QA inspections

Use of Instron blue hill software versions 2 &3 Machine #5567, inventory cycle counts FIFO, worked with packaging line mechanics

Operate PLC high speed packaging machines, trouble shoot, equipment, machinery, expedite & order parts, perform changeovers

EHS & safety training, operate large commercial parts washers, Oracle, SAP, FDA code of regulations 21 CFR 820 & Parts 210, 211

Batch records review, assist engineers in establishing AQL on batches perform preventative maintenance on packaging machines

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

Fairleigh Dickinson University Accounting Major, Teaneck, New Jersey – 36 Accounting Credits

Worldwide Services Business School, Computerized Bookkeeping, Hackensack, New Jersey – Certificate Received

Packaging Operator/Material Handler LanXess Corp. 05/2024 - 02/2025

East Hanover, NJ

Assist in warehouse operation of packaging line machinery, proof read labels, wear PPE clothing, hazmat training received

Take waste materials to the hopper/compactor, fill containers with chemicals with fluids & grease for turbine airplane and helicopters Manufacturers of specialty liquids, fluids for the military, daily safety meetings, pilot plant operator, count inventory Handled samples and provided them to the QC labs, attend weekly packaging meetings & chemicals storage. Operate material Handler equipment Inspect containers coming off the line for leakage, damage & proper expiration dates, follow GMP regulations. Work on large size packaging line 1 quart, 4 quart & 5 gallon cans, inspect labeling, lot codes and leakage on bottom of containers, after use of the hopper bundle cans waste materials with metal wire dispose of in refuse trailer for pick up

Caregiver for Elderly Senior/Full Time 08/2022 – 05/2024

Little Ferry, NJ

Provide physical therapy, food shopping, clothes shopping, cooking meals, cleaning, assist Warren in the shower, shaving getting dress, pick up medications, give Warren his daily does of medications, drive to doctor’s appointments, converse with allDoctor’s, drive to place of worship, take him on joy rides, pay bills handle finances & taxes & provide tender loving care

Production Operator Sterilization Sanofi Pharmaceuticals 03/2022 - 08/2022

Ridgefield, NJ

Operation of mfg. machinery, generate product labeling for autoclave items manufacturing of Synvisc Gel, prepare bulk solution

for aseptic fills of Buffer cleaning agents, packaging technician, sterilization of clamps, hoses, gaskets, machine parts & products

Hectorol, Synvisc, Mozobil, Jonexa & other products used in manufacturing, using Fedegari & SBM autoclaves, deep cleaning

of glass & machine parts using Girton, Belimed 1 & 2 high powered washers using strong detergents, pilot plant operator

Clean & sanitize clean rooms, wash floor & walls in clean rooms with wet mop don’t dry, perform label inspections on products

disassemble & assemble parts for aseptic cleaning and to be autoclaved, operate packaging machine, received GxP training, sample lots for product, assisted on packaging syringe Line placed rejected and rework syringes in proper containers, stand up entire shift

Clinical Trial Kit Builder – Regeneron Pharmaceuticals 12/2020 – 06/2021

Tarrytown, NY

Assembly of all clinical trial kit configurations, oversight of the storage of kit components under secure temperature controlled environments per cGMP guidelines & regulations, pick & fill site orders from inventory stock, format & proof read labels, ordered materials for clinical trial kits, prepare & pack shipments, create product labels, supply chain duties, order vials & tubes from BD Co. GxP lab practices, add received items into inventory stock, dispose of expired materials, receive and inspect incoming customer returned product, collaborate with Regeneron Clinical Operations, QA, & Lab Operations through Microsoft Teams program, perform other duties per QC Lead & Regeneron Management Personnel, all work is compliant with 21CFR, ISO 13485 per cGMP standards, adhere to Regeneron’s covid19 masking & sanitizing rules, package & ship orders to hospitals, review batch records prior to QA Inspection, I received my first covid19 (2) shots in May & June onsite while working at Regeneron Pharmaceuticals

Feeder Associate/Dispatch Assistant – United Parcel Service 10/2020 – 12/2020

Saddle Brook, NJ

Inspected 120 – 170 trailers on 3rd shift for left over packages in the trailers, check current trailer registration stickers, bring

Left over packages to the hub have them scanned into the system placed on the various belts and resorted, follow safety

Protocols when going in trailers, inspect package labels on boxes, notify drivers the trailer is being inspected, during my

tenure at UPS I have found 8 packages. I followed Covid-19 safety rules, physical distancing, wearing a mask inside at all times Worked outside in all weather conditions, received praise from supervisor being a trustworthy, reliable good worker

Packaging QA Line Operator – Mondelez/Nabisco 05/2020 – 08/2020

Fairlawn, NJ

Place cookie boxes on conveyor belt check expiration date, code date, weigh product for gross & net weights inspect for labeling

Clear line jams, restart machine, input all data into computer fill out production reports, packaging of OTC snacks, test packaging

Major cleaning & switch over to new product, wear all PPE, inspect cookies samples & bags every half hour for holes dispose of

Rejected cookies in marked bins, work with AQL samples on the line follow safety rules FDA & cGMP perform lockout/tag out

Operate PLC machines in the packaging department baggers, feeders, shrink wrap report mechanical issues to line lead

Training for Covid19 gowning, face mask, gloves, hairnet, gather cardboard, straps, labels and other packaging materials

Material Handler II Supply Chain – Immunomedics Corp 07/2019 – 01/2020

Morris Plains, NJ

Load trucks of hazmat materials and GXP & GMP materials, delivery of materials between buildings 410 & 300, receive deliveries

From UPS & FedEx, Inventory & count all tems for delivery to building 300 for QA personnel to inspect, perform cycle counts on

materials received from building 410, created labels for product place on the boxes till QA releases the product put items away in

the stage & quarantine areas in the warehouse, move 50, 90, 100 & 200 liter drums of water & chemicals, sign batch logs

Use of electric pallet jack, crown fork lift truck & drum lift equipment, wear PPE items steel toe shoes, gloves safety glasses

Sample management of chemicals. I originated the idea of shrink wrapping or use of cloth straps for all drums being delivered to building 300 to prevent tip overs during the unloading process. Store hazardous chemicals separate, deliver samples to QC Dept.

Sign & audit batch records ticket, inspect products and labels on drums of chemicals, load and unload trucks, arrive to work on time

Maintain log book to record temperature twice daily in building 410 warehouse, ask warehouse supervisor or executive director of supply chain to verify all my work that I picked before delivery to building 300, write very neatly on all documents in a GXP facility

Use of Great Plains system to track movements of inventory in the system, be a part of the supply chain team, tracking inventory

Complete all job task assignments from mfg. Operations, Quality assurance, warehouse & from supply chain bill of material invoices

Caregiver for Elderly Senior/ Part Time 12/2018 – 07/2019

Little Ferry, NJ

Provide physical therapy, food shopping, clothes shopping, cooking, cleaning, assist Warren in the shower, getting dressed

Pick up medications, give him daily dosage of medications, drive to doctors appointments, place of worship, supermarket,

Joy rides to parks, restaurants, give him tender loving care empathy, arrange parties at his home, emotional support, hugs,

Production Operator Inspector – Instrumentation Laboratory 09/2018 – 12/2018

Orangeburg, NY

Handle and dispose of used blood containers left over in the instruments returning from the hospitals & urgent care centers

Dispose of biohazardous waste chemicals & materials work on assembly line and perform multiple inspections EHS training

Work in cGMP manufacturing area, label inspection filled 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 Received EHS

training for disposal of hazardous chemicals & safety,use of various types of fire extinguishers, cleaning of the plant facilities

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 deliver samples to QA Dept. for analysis, locate chemicals & released materials

check labeling on products check lot codes & item numbers, used PPE, gowning, nitrile gloves, steel toe shoes, hairnet, mask

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, air samples taken

Input inventory counts on excel spreadsheets for manager to view, provide sample management of all samples I collect

Perform shop floor audits on chemicals & powders handling questions on the samples and chemicals, check batch records

Automotive Safety Inspector – Foreign Auto Preparation Service 11/2017 – 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

Worked with regulatory affairs & Quality auditors answering questions on the cars that were inspected

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

Leonia, NJ

Responsible for blending the product per formula instructions, also follow all SOP’s & cGMP’s, collect vitamin samples for QA dept

Operate machines generate labels with batch records per SOP’s, physically load & unload blending machines, monitor blending

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

Perform major cleaning of machinery & equipment on a daily basis with industrial cleaning solvents fit for respirator & mask

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

Quality/ Mechanical Inspector – Zimmer-Biomet Inc. 08/2016 – 03/2017

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 reports on materials 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 sample management of all titanium samples, check with supervisor to validate questionable material measurements, review batch records, release batches of titanium stock for the QC Dept. for use on the production floor, CFR 820 parts 210, 211 Received EHS training

Quality/Inventory Coordinator – ZT Systems, Inc. 03/2016 – 06/2016

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 Quality Assurance personnel on identifying nonconforming material write CAPA report if necessary, supply chain warehouse

Input line items on excel spreadsheets & generate reports for management, check for SPL labeling on boxes

Pharmaceutical Packaging Technician – Halo Pharmaceuticals, Inc. 01/2016 – 03/2016

Whippany, NJ

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

Final of 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, input batch records

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 five supervisors & the manager say I was the best Yard Checker they had in many years working for them, I was given full time hours

Medical Device Technician – Pentax Medical, Inc. 10/2013 – 08/2014

Montvale, NJ

Recently taken course on EHS, Environmental Health & Safety & chemicals storage, audit batch record for accuracy

Inspect & sterilize Endoscopes, Bronchoscopes & medical devices per SOP specifications, inspect product labels

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

Packaging Mechanic Trainee – Novartis Pharmaceuticals, Inc. 06/2012 – 05/2013

Suffern, NY

Proof read labels per master label guide SOP, 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

CAPA, try to increase production times, assist in new design of packaging labels per SOP’s, check travel ticket router

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 move drums of cleaning solvents Assist in packaging of asthma nasal spray & other inhalants also bubble blister pack medications EHS training for chemicals

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 defect 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

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

Accomplishments:

I have 11 years full time experience as an Accounts Payable Specialist which is on another resume, pilot plant operator

Lead a team of 5 inventory cycle counters for accurate counts on merchandise & finished goods in the warehouse

Found empty sealed bubble blister package with no tablet inside ready to be shipped out on the production floor

I stopped the production line reported the blister pack problem to my supervisor received free lunch for my team mates & myself!

I have 3 years of supervisor & lead person experience, arrange for cycle counts during company 6 months inventory counts

Served as a compassionate caregiver to an elderly friend with dementia provided physical therapy, tender loving care for 5 years!

Served on safety committees found unsafe conditions in the factory on my weekly rounds reported findings to management!

Always displayed fine people & communications skills with all people avoiding arguments being a people person & peacemaker!

Started the idea of shrink wrapping all pallets going to QC Dept. while working at Immunomedics Corp, management approved it!

Admit my errors & mistakes to my supervisor ask for advice to prevent it happening again, ask for help when not sure of a job task!

Willing to go outside and inspect trailers in all types of weather while at UPS received praise from the manager being best worker!

Practice safety at all times don’t take chances wear the proper PPE atire, train others about safety, ask for help with heavy boxes

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