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Manufacturing Operator II, Fill Label, Pack

Company: Ortho-Clinical Diagnostics
Location: Pompano Beach
Posted on: June 9, 2021

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 are seeking a Manufacturing Operator II in the manufacturing/production department. This position is responsible for performing manufacturing procedures and executing diverse tasks in various manufacturing areas related to Filling, Labeling, Packaging and Line Tending according to detailed operational specifications and execution of scheduled tasks within a cGMP environment. While ensuring 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. This position is located in Pompano Beach, Florida.

This is a third shift position. 10:00pm to 6:30am

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: (Fill, Label, Pack equipment, testers, scales and printers) list is not all inclusive
  • Check products online 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

Additional Responsibilities/Duties:

  • 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)

Support the ongoing production schedule by:

  • Report to work on-time and according to the shift schedule.
  • Perform other duties as assigned.
  • Attend departmental and other scheduled meetings.
  • Practice good interpersonal and communication skills.
  • Demonstrate positive team-oriented approach in the daily execution of procedures.
  • Promote and work within a team environment
  • Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
  • Assist with validation activities in the area
  • Responsible for audit preparation and participation

The Individual

Education and Experience:

  • Minimum of 2-4 Years MD&D/Pharmaceutical experience or equivalent industry experience
  • High School diploma required

Autonomy and Complexity:

  • Needs some direction to perform manufacturing daily tasks within functional area.
  • Performs and has good understanding of processes and procedures.
  • Assist with validation activities within the area.
  • Notifies Shift Leader or Supervisor of maintenance and/or repairs needed on manufacturing equipment or processes
  • May assist in troubleshooting of routine manufacturing equipment/ processes

Nature of Tasks:

  • Good mechanical and troubleshooting knowledge within functional area
  • Demonstrate a good understanding of the process in order to properly perform the assigned manufacturing tasks
  • Identify discrepancies or trends that might need additional attention and notifies supervision.

Computer Ability:

  • Good working knowledge and understanding of systems as required.
  • Utilizes tools within MS Office and other systems to improve business effectiveness.
  • Accurate Data Entry skills in ERP system

Language and Skills:

  • Ability to read, write and speak English
  • Read and interpret documents such as safety rules, operating instructions and logbooks
  • Review and provide feedback for SOP and Batch Record Revisions
  • Good communication and written skills

Mathematical Skills:

  • Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.

Other Skills and Qualifications:

  • Understand Lean principles as it relates to work
  • Understand Value Stream maps and relevancy
  • Actively participates in Kaizen, problem solving and asset care

Physical Demands:

While performing the duties of this job, the employee:

  • Is frequently required to communicate with coworkers.
  • While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms for extended periods of time.
  • Must pass vision acuity test for inspection of work in process and finished goods
  • Ability to lift up to 40 lbs.
  • Work with blood, blood products and chemicals
  • Overtime is required, as necessary
  • Shift work may be required, as necessary
  • Periodic exposure to 2-8C temperature controlled coldbox during product transfer

Keywords: Ortho-Clinical Diagnostics, Pompano Beach , Manufacturing Operator II, Fill Label, Pack, Other , Pompano Beach, Florida

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