Manufacturing Operator II
Company: Ortho-Clinical Diagnostics
Posted on: January 15, 2022
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
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
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.
* Execute manufacturing or manufacturing-support processes
according to standard operating procedures and current
* 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
* Take samples for further downstream testing and perform tests
during processing according to standard procedures
* Use of ERP system for performing material
* Cleans , maintains, and performs basic repairs on equipment as
* Operate and troubleshoot equipment in clean room and non-clean
* 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
* Monitor environmental conditions inside and outside classified
* Wear the appropriate PPE when working in manufacturing and other
* 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
* 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
* Perform other work-related duties as assigne
* HS Diploma or GED equivalent required
* 2+ years of MD&D/Pharmaceutical experience or equivalent
* Good working knowledge and understanding of systems.
* Proficient with MS Office and other systems to improve business
* 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
* Basic math skills; add, subtract, multiply and divide in all
units of measure, using whole numbers, common factions, and
* 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
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.
Keywords: Ortho-Clinical Diagnostics, Trenton , Manufacturing Operator II, Other , Raritan, New Jersey
Didn't find what you're looking for? Search again!