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Manufacturing Operator II

Company: Ortho-Clinical Diagnostics
Location: Raritan
Posted on: January 15, 2022

Job Description:

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

As we continue to grow, we're looking for a Manufacturing Operator II. This position is responsible for performing manufacturing procedures and executing diverse tasks in various manufacturing areas related to Filling, Labeling and Line Tending according to detailed operational specifications and execution of scheduled tasks within a cGMP environment. Ensure materials are available to meet production schedule. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations. Accountable for adhering to all EHS guidelines.

The Responsibilities

* Execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.


* Support schedule adjustments to meet production, material receipt and shipping requirements.


* Work with Shift Leader//Team Leader to review departmental production schedules, work orders and related information to ensure materials are available for production.


* Maintain working knowledge of cGMP requirements to ensure adherence to compliance policies and regulations


* Sets up and operates production equipment to produce work in process and finished goods


* Perform in-process testing as required by processes and procedures utilizing equipment such as: (Fillers, Labelers, ELISA plate equipment and pouchers, autoclave, oven, torque testers, scales and printers) list is not all inclusive


* Check products on line to confirm proper assembly and remove defective products


* Take samples for further downstream testing and perform tests during processing according to standard procedures


* Use of ERP system for performing material transactions/moves/quantities/cycle counts


* Cleans , maintains, and performs basic repairs on equipment as needed


* Operate and troubleshoot equipment in clean room and non-clean room environment


* Assure manufacturing facility and equipment meets all requirements prior to production on all shifts.


* Accurately complete documentation in batch records, logbooks, forms and other GMP documents.


* Verify and enter production parameters per SOP and Batch Records.


* Monitor environmental conditions inside and outside classified rooms


* Wear the appropriate PPE when working in manufacturing and other working environments.


* Demonstrate training progression, train designated personnel in all levels of responsibility


* Understand Lean principles as it relates to work


* Understand Value Stream maps and relevancy


* Actively participates in Kaizen, problem solving and asset care


* Proactively maintain a clean and safe work environment by performing sanitizing and housekeeping duties and looks for opportunities to improve. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors


* Offer suggestions and follow up on process improvements related to safety, compliance, cost, yield and productivity.


* Carry out duties in compliance with all state and federal regulations and guidelines including FDA, TUV, EPA and OSHA.


* Adhere to the safety code of Conduct & Ortho EHS policies and attend all required EHS training.


* Follow Global Leadership Profile (GLP) competencies based on their leadership level within the organization (individual leader)


* Perform other work-related duties as assigne



The Individual

* HS Diploma or GED equivalent required


* 2+ years of MD&D/Pharmaceutical experience or equivalent industry experience


* Good working knowledge and understanding of systems.


* Proficient with MS Office and other systems to improve business effectiveness.


* Good Data Entry skills in ERP system


* Good communication and written skills


* Able to read and interpret documents such as safety rules, operating instructions and logbooks


* Review and provide feedback for SOP and Batch Record Revisions


* Basic math skills; add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.


* Ability to push, pull and lift up to 40 lbs.


* Comfortable working with blood, blood products and chemicals


* Prior experience working in a cGMP area and/or clean room environment



Key Working Relationships

* Internal - Coworkers (other Line Tenders) - Communicating on what components need to be prepped and ensuring Filling/Labeling has needed supplies. Filling/Labeling - Making sure they have components, supplies and paperwork as required for tasks. Shift Lead - changes to schedule and any issues during runs. Supervisor - Quality or personnel issues or questions.



EOE/AA Disability/Veteran

Keywords: Ortho-Clinical Diagnostics, Trenton , Manufacturing Operator II, Other , Raritan, New Jersey

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