Manufacturing Associate Environmental Monitoring
Resume:
Juan L. Ramos
New Brunswick, NJ 08901
*********@*****.***
Efficient Manufacturing Associate with years of experience working within the FDA regulated industry. I have demonstrated the ability to work independently or as part of a team to complete tasks quickly and accurately. Seeking a position where I can use my experience and efficiency to contribute to the company’s success whilst growing personally and professionally.
Novartis Pharmaceuticals
Cell Processing Specialist 7/2023 -5/2024
Responsible for cell washing operations and verifying cell processing intermediate processing days of patient derived clinical and commercial cellular immunotherapy products.
Responsible for the formulation and verification of all media lots.
Gowned aseptically and worked in clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time for the purpose of cell washing with automated equipment.
Verification of intermediate process days which include expertise with the wave bioreactor, NC-200 and in process environmental monitoring.
Maintained and prepared equipment/environment for use, proficient in the use of production related IT systems such as SAP, LIMS and MES, documents all steps in the assigned batch record in line with GMP requirements.
Conducted all necessary processing/verification steps for the assigned lot with highest skill level of aseptic technique.
Conducted all necessary processing/verification steps for assigned lots of media with the highest skill level of aseptic technique.
Conducted routine and dynamic environmental monitoring as required.
Assisted on Deviation Investigations and Inspections and participation in assigned qualification/ validation activities.
Responsible for successful on time completion of required training curriculum comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
Familiarity with NucleoCounter NC-200, Bioreactor, Cytiva GE Xuri Cell Expansion System W25 and W5 system, Flowstar IV and V, Filter Integrity Tester and Haemonetics Cell Saver 5+ Autologous Blood Recovery System
Bristol Meyers Squibb 08/2020-6/2023
Environmental Monitoring Technician
To collect data within the lab environment as well as associates operating on processes to ensure compliance with regulations to identify potential hazards.
To conduct field inspections and follow procedures to ensure compliance to collect air samples.
Record and report findings including deviations from established standards.
Assist with the implementation of environmental monitoring programs to improve process flows, eliminate waste, and improve quality.
Train other personnel on proper sampling techniques.
Maintain accurate and detailed records of monitoring activities, results, and reports.
Exhibit strong communication skills to effectively convey findings and recommendations to improve process steps, demonstrated attention to detail.
Demonstrate the knowledge of environmental compliance, safety protocols as per Standard Operating Procedures (SOP).
Manufacturing Associate CAR-T
Following the Standard Operating Procedures to produce CAR-T cells, including cell culture and reagent/Media production within the cleanroom setting.
Operating and maintaining equipment used in the production process such as centrifuges, Cell sorters, incubators, filtration systems.
Documenting production data and maintaining accurate and detailed records of all activities within the lab in compliance with cGMP and cGDocP as part of the regulatory guidelines of 21 CFR part 820.
Provided training and guidance to other member of the Manufacturing team.
Participated in continuous improvement activities to identify opportunities for process improvement.
Collaborate with other departments such as Quality Assurance to ensure compliance with regulatory requirements.
Worked well within a team environment.
Integra Life Sciences 02/2020-07/2020
Clean Room Operator
● Operate, maintain, and troubleshoot process equipment utilized in the collagen business, and can make minor equipment adjustments as needed
● Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches
● Blend, mix, pour, and load collagen prepped material into lyophilizing equipment.
●Pass and maintain gowning qualification to perform Gowning Requirement for ISO Class 5 Clean room operations or ISO Class 7 Clean room operations.
●Responsible for accurately maintaining legible and accurate records, required logs, books, and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements.
●Interface with QA/QC/Material departments during course of work to coordinate inspections and efficient flow of subassemblies and completed product.
●Enter and record production activities in Oracle MRP systems to issue material and labor hours to specific work orders.
●Follow applicable Standard Operating Procedures, Quality System Regulations and ISO 13485 requirements.
●Responsible for handling, decontamination, and cleaning of production supplies, instruments, equipment to support all cleanroom production related activities
●Responsible for reporting all discrepancies to the Supervisor or Group Leader.
●Support department and plant Safety goals by continuously demonstrating safe behavior
●Maintain a clean and orderly work area
●Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements
●Perform other manufacturing activities as assigned by the department leadership
Allergan Pharmaceuticals 6/19-10/19
Processing Technician
●Reads, comprehends, and adheres to all appropriate standard operating procedures
●Wears appropriate attire/PPE (personal protective equipment)
●Prepares safe, quality tissue and maintains aseptic technique
●Reads digital timers and/ or clocks and convert standard time to military time
●Measures, labels, and packages all tissue accurately and according to standard operating procedure
●Performs quality inspection review of all processed tissue and paperwork
●Attends all related team meetings and skills training as required
●Keep work area and all work surfaces clean and orderly
Musculoskeletal Transplant Foundation/ Insight Global 5/18- 1/19
Process Technician
●Reads, comprehends, and adheres to all appropriate standard operating procedures
●Wears appropriate attire/PPE (personal protective equipment)
●Prepares safe, quality tissue and maintains septic technique
●Reads digital timers and/ or clocks and convert standard time to military time
●Measures, labels, and packages all tissue accurately and according to standard operating procedure
●Performs quality inspection review of all processed tissue and paperwork
Apex Life Sciences / Roche Pharmaceutical 9/25/17-3/25/18
Diagnostic Technician Associate
●Performs tube/frame assembly, filling, labeling and pouching operations consistent with Roche quality standards.
●Follows all department work instructions, SOPs, OSHA safety regulations and executes all manufacturing activities in accordance with cGMP/cGDocP/cGLP guidelines.
●Performs in-process quality checks for specific quality attributes (fill check, torque check and label alignment check). Inspects products for defects and conformance to quality standards in accordance with cGMP/cGDocP/cGLP guidelines.
●Wears protective gowning as manufacturing steps are performed in an environmentally controlled area.
●Uses basic laboratory equipment to complete manufacturing and filling activities including pipettes, scales, lyophilizes, etc.
●Completes necessary filling documentation (production manufacturing records) and associated SAP transactions to ensure all components meet requirements pertaining to lot numbers, expiration dates, intermediates, reconciliations, etc.
●Cleans work area and decontaminates work surfaces in accordance with defined procedures and performs duties in accordance with SOPs, QSRs, and all safety regulatory requirements.
●Monitors laboratory supply inventory replenishes lab supplies as needed. Performs general/routine laboratory maintenance/upkeep.
●Communicates and interfaces directly with internal groups to ensure that laboratory equipment maintenance and calibration are completed as scheduled.
●Performs material handling activities according to defined procedures, which includes picking, issuing, stock transfer and receipt transactions.
Integrity Staffing Solutions/ Amazon Fulfillment Center 11/16- 3/17
Warehouse Associate
●Pick items in a timely manner that come across the screen for each particular order to be
sent out for delivery the next day.
●Provide every workstation with proper totes to ensure packages can be moved along
conveyor belt to shipping department for next day delivery.
●Support all other departments with assistance with day-to-day actives to ensure proper
daily activities are kept up to Amazon Fulfillment Standards.
Aprecia Pharmaceuticals Company 02/16- 09/16
Pharmaceutical Technician 1
●Ensure the product is being manufactured with strict adherence to all Processing,
Quality, Safety, and Environmental SOPs, guidelines and Policies.
●Set up, Operate, Monitor, Clean, and Maintain various Processing, Packaging and
Testing Equipment, as well as their associated rooms.
●Assist in certain maintenance activities to ensure repairs, routine preventative
maintenance, and calibrations are performed in a timely manner with minimal
impact on processing schedules and complete adherence to procedures and
Quality, Safety, and Environmental Guidelines.
●Ensure appropriate actions are taken in the event of Deviations and Emergencies.
●Ensure that Batch Records and all associated process documentation are completed
as they occur and done right the First Time by utilizing manufacturing and documentation
policies and procedures.
●Communicate Batch/Equipment status and issues to supervisor and other operators.
●Trained in all areas (primary packaging, 3DP (three-dimensional printing), and compounding)
to successfully rotate between the functional duties and support changing production needs.
Integrity Staffing Solutions/ Amazon 08/15-02/16 Employment Recruiter/ Warehouse Trainer
●Interviewed potential candidates for various positions within Amazon Fulfillment
Centers throughout the NY & NJ areas.
●Gathered all documents such as Proof of Identity, HS Diplomas, Birth Certificates, Passports,
Work Visa, Green Card authorization both Foreign and Domestic.
●Positions included but not limited to, Picking, Packing, Shipping, Receiving, Stowing.
●Administered on the spot Drug Test to all applying applicants in ensure all applicants
meet the Drug Free criteria for positions with Amazon Fulfillment Centers.
●Ensured that all 1st, 2nd, and 3rd shifts were staffed to meet the demands of Amazon's
Fulfillment Centers.
Corinthian Colleges Inc. 1/10- 10/12
Everest Institute (South Plainfield Campus) Admissions Representative
●Receive inquiry calls from all potential students interested in knowing or receiving
information about the programs, including entrance requirements, curricula and
academic standards.
●Return inquiry calls promptly to all potential students and give accurate information
about the programs including entrance requirements, curricula, and academic standards.
●Follow up on all inquiries that fail to schedule an interview or fail to show for an
interview.
●Utilize an approved telephone presentation and interview procedure during the
enrollment process.
Key strengths and skills:
GMP Certified
Environmental Monitoring Technician (EM)
Bilingual (Spanish)
Excellent Customer Service Representative with over 25 years of experience in sales and cash handling
Professional organizational and time management skills, detailed oriented
Training and Management experience
Strong verbal and written communication abilities
Bookkeeping experience
Proficient in Microsoft Office Suite
Education: Union County College, Cranford, NJ 09/02- 11/03
Associate Degree in Communications/Public Relations
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