Packaging Equipment Pharmaceutical Manufacturing
Resume:
Denise L. Nobles
(Franklin Park),
*************@*****.***
● Experienced Manufacturing professional with 4+ years of experience working with pharmaceutical industry.
● Proficiently operated and monitored pharmaceutical manufacturing equipment according to SOPs and safety guidelines.
● Operated various process equipment including reactors, pressure filters, pumps, filling, labeling, and packaging equipment according to written SOP's and UOP's.
● Well versed with Cell culture utilizing aseptic technique cell banking, cell expansion using flasks, cell expansion Hyper Stacks, and bioreactors and sterilization of processing equipment using Autoclave.
● Operate basic equipment (i.e., scale and/or balance autoclave PH meter, environment monitoring equipment as deliberately in standard operating procedures.
● He is fully vaccinated – local to Franklin Park, NJ. Education:
Kean University, Union, NJ
Bachelors in criminal justice – Minor: in Chemistry, Presently Enrolled Union County College, Cranford, NJ
Associate in criminal justice.
Certifications:
CPR/AED
Professional Experience:
AstraZeneca, Bensalem, PA Jan 24 - Present
Manufacturing Technician
● Operated and monitored pharmaceutical manufacturing equipment according to SOPs and safety guidelines.
● Conducted equipment setup, cleaning, and changeovers to support production schedules.
● Assisted in the troubleshooting of equipment and process issues to minimize downtime and maintain product quality.
● Collaborated with Quality Assurance to perform in-process checks and ensure compliance with regulatory requirements.
● Operate various process equipment including reactors, pressure filters, pumps, filling, labeling and packaging equipment according to written SOP's and UOP's.
● Completed documentation supporting preparation of production supplies and label inspection through interface with SOPs (processing instructions), data collection systems, and use of packaging equipment.
● Cell culture utilizing aseptic technique cell banking, cell expansion using flasks, cell expansion Hyper Stacks, and bioreactors.
● Sterilization of processing equipment using Autoclave.
● Strong understanding of GMP and regulatory requirements.
● Excellent troubleshooting and problem-solving skills.
● Participated in continuous improvement initiatives to optimize manufacturing processes and increase efficiency.
Cytosorbents Medical, Inc, Princeton, NJ May 2023 – Aug 2023 Production Operator
● Manufactured product according to company processes, procedures and GMP requirements
● controlled equipment units or system that processes chemical substances into specified products.
● Observed chemical reactions; monitored gauged, signaled, and recorded.
● Provided leadership in handling hazardous materials and hazardous waste in compliance with local, federal, and company guidelines.
● Practiced appropriate clean room operations while assembling and handling the CytoSorb device.
● Recorded detailed operating data such as process conditions, test results, and instrument readings.
● Performed activities associated with packaging products and materials for storage or shipment. Sun Pharmaceutical Industries, Inc., New Brunswick, NJ Jun 2022 – Jun 2023 Manufacturing Encapsulation Operator II
● Worked in antiseptic sterilization. Developed organization-wide culture focused on reviewing batch records.
● Was comfortable working in PPE and in a clean room environment Performed functions relating to the processing of drug products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements, and in conjunction with all Standard Operating Procedures (SOPs).
● Experienced in dealing with FDA and DEA while ensuring the safe and efficient execution of job duties.
● Troubleshot and made appropriate adjustments to maintain production specifications.
● Adhered to quality standards during the manufacturing process.
● Operated equipment for production processes: Granulation, Blending, Compression, Coating, Imprinting, Banding, and Encapsulation.
Amneal Pharmaceuticals Piscataway, NJ Mar 2022 – Jun 2022 Manufacturing Transdermal Operator 1
● Provided leadership and assisted with equipment set-up, IQ/OQ/PQ, and commercial batch activities.
● Efficiently setup and operated latest cartooning machine to process and package transdermal products.
● Performed packaging room clearance, count material available, and reconcile items as per GMP and SOP.
● Operate basic equipment (i.e., scale and/or balance autoclave PH meter, environment monitoring equipment as deliberately in standard operating procedures.
● Handled in-process checks, visual inspections, routinely inspected transdermal products for quality i.e. proper placement of cutting, printing, and sealing of the product. Followed room and equipment cleaning procedures. Documented in-process checks and ensured all batch record data was accurately recorded.
● Cleaned assigned work areas and assisted in maintaining a clean, orderly, and safe work environment. American Spraytech, Branchburg, NJ Jan 2022 – Mar 2022 Production Line Leader
● Performed machine setup for efficient operation of packaging lines. Ensure product change-over according to the SOP requirements. Maintained updated knowledge of the repairs, preventative maintenance, and daily support of packaging equipment in the manufacturing of aerosol products.
● Optimized time and resource allocation techniques, and performance within manufacturing specifications.
● Assembled, operated, disassembled, and cleaned equipment. Performed routine calibration/adjustment.
● Completed documentation supporting preparation of production supplies and label inspection through interface with SOPs (processing instructions), data collection systems, and use of packaging equipment. Viant Medical Jersey, South Plainfield, NJ Nov 2021 – Jan 2022 Quality Control Inspector
● Experienced in reading and interpreting blueprints, including GD&T. Provided leadership in inspecting and measuring parts for production, process validation, and support of engineering and quality control.
● Maintained measurement records. Gaged calibration and training of operators in inspection techniques.
● Helped develop, modify, and maintain quality standards and evaluation methods (products/processes). Ras-I Laboratories, East Windsor, NJ Sep 2021 – Oct 2021 Compression/Encapsulation Operator
● Led in setting up tableting machine, semi-automatic and automatic high speed encapsulation machines.
● Provided leadership in verifying correct blend and tablet/capsule size; feeding material into hopper throughout the run; gathering samples and bringing samples to QC for rapid approval.
● Reported all deviations of tablet/capsule weight, size, dissolution, and improper sealing to supervisor.
● Observed quality protocols while meeting/exceeding production capacity by feeding material into hopper. L'Oreal, Somerset, NJ Jul 2021 – Oct 2021
Machine Operator
● Applied knowledge of the production process, items produced, and equipment utilized in maintaining production within specific standards.
● Maintained a safe work environment and followed safety procedures.
● Led in TPM methodologies on lines and willing to use hand tools to address various maintenance needs. Luptin Pharmaceutical, Somerset, NJ Jun 2021 – Jun 2021 Filler / Packer – Packaging Department
Accurately identified medications required to be ordered for packaging to ensure availability of inventory. Provided leadership in cleaning packaging materials, loading items into containers, and labeling items appropriately. Performed final checks for defective items. Kept detailed records of materials/shipments. Led in achieving production requirements, ensuring quality and safety-related standards were maintained. Spectrum Chemical Laboratory and Pharmacy Products, Cranberry, NJ Jun 2021 – Jun 2021 Chemical Operator / Security Analyst
Inspected labels against label proofs and other supporting documentation for confirmation of but not limited to the following characteristics: count, variable text, character verification, and chemical defects. Permitted authorized persons to enter property and monitor entrances/exits. Observed departing personnel to protect against theft of company property and ensure that authorized removal of property was proper. Early Career Experience:
NJ Department of Corrections, Trenton, NJ Jan 2000 – May 2015 Senior Corrections Officer (Retired)
● Experienced in facility safety and fire related building policies/procedures and enforced them appropriately. Inspected fire protections devices to ensure compliance to fire and safety standards.
● Continuously prevented crimes by immediately reporting all unusual, unauthorized, and illegal activity. Responded to calls.
● Immediately reported fires, accidents, and other safety hazards.
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