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Operations

ABS PRE-PROCESSING LEAD

  • Titel ABS PRE-PROCESSING LEAD
  • Functie Operations
  • Sub functie Production
  • Locatie Cornelia, Georgia, United States
  • Gepost
  • Referentie 2206089191W
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Beschrijving

Ethicon Inc. (6045) is currently recruiting for an ABS Pre-processing Lead located in our Cornelia, GA site.

JOB SUMMARY

Responsible for using equipment for the assembly and processing tasks to produce finished products according to established specifications. Accountable for adhering to all quality and safety guidelines

DUTIES & RESPONSIBILITIES

Under general direction/supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

  • Operates production equipment to produce subassemblies or finished products. Interprets instructions and specifications and uses to set up equipment.
  • Checks products on assembly line to confirm that they are properly assembled and removes defective products.
  • Cleans and maintains equipment as needed.
  • Notifies supervisor of maintenance and/or repairs needed on equipment.
  • Prepares accurate records/documentation related to quality and work in progress. Troubleshoots minor production problems
  • Must cross train on all jobs in department based on business need and be able to fill in for associates as needed.
  • Train personnel in the area. See cross training jobs listed below.
  • Coordinate and lead day-to-day activities in the production manufacturing area as necessary, in alignment with immediate or direct supervision.
  • Responsible for delivering departments outputs daily for assigned shift
  • Monitor assigned area and reallocate resources as necessary to meet schedule requirements within the department.
  • Prepare weekly staffing plan for the area.
  • Reports any associates who are not behaving in accordance with the J&J established policies to the Line Facilitator or Manufacturing Manager as applicable.
  • Demonstrate leadership by delegating work of others, gather information and complete reports as requested.
  • Demonstrates leadership by assisting in the hiring and review process, help schedule overtime, work assignments and vacations, move associates to level workloads and meet daily production requirements.
  • Demonstrates leadership qualities.  Create and actively pursue a team-based, non-threatening environment designed to promote teamwork and open exchange of ideas.
  • Leads Crossover meetings and ensures cross shift participation. Frequently identify and communicate progress and areas of improvement to team members.
  • Responsible for schedule attainment.
  • Collaborate with Supervisor on all department performance and operator issues, coordinating priorities with other shift Leads.
  • Oversee and coach associates through basic performance problems
  • Ensures that employees within shift are adhering to GMPs, GDPs and acting in accordance to their process specifications.
  • Responsible for training adherence for the shift.
  • Escalates any major safety, quality or equipment downtime situation to the Shift Line Facilitator or the Manufacturing Manager as applicable.
  • Promotes a safety focused culture and the Good Saves program within his Shift.
  • Responsible for ensuring sustainability of the 6S program.
  • Responsible for cleanliness of the area.
  • Responsible for maintaining all assigned work areas safe, clean and in good operating condition
  • Maintain and troubleshoot equipment.
  • Support projects and validations as needed.
  • Support others in troubleshooting equipment issues.
  • Provides recommendations and opportunities for OEE improvements.
  • Opens work orders if repairs are required in the facilities or the equipment.
  • Demonstrates consistently effective job performance that encompasses good quality and quantity of work, and dependability.
  • Communicates problems and potential solutions to supervisor, technician, engineer and incoming production shifts. 
  • Demonstrates ability to manage complexity.
  • Promotes innovation and continuous learning to other associates.
  • Order Raw Materials to warehouse as needed
  • Responsible for communicating business related issues or opportunities to next management level
  • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed

PDS and Monocryl Processing

Rackwinding:

  • Use rackwinding machine to wind spools of Monocryl and PDS fibers for further processing.
  • Create and verify tickets and labels.
  • Open cans as needed. Verify moisture content is within specification.
  • Place material into nitrogen/vacuum chambers as needed. Verify chambers are sealed.
  • Complete required information on the Device History Record (DHR) and other related forms.
  • Follow line clearance procedure.

Annealing :

  • Load racks into appropriate annealing oven and select appropriate cycle.
  • Place chart on required oven and lock into place.
  • Make periodic checks of the ovens to ensure running within specification.
  • Verify chart for accuracy and that all requirements are met at cycle completion.
  • Keep track of cleaning schedule and identify ovens requiring cleaning.
  • Complete required information on the Device History Record (DHR) and other related forms.
  • Follow line clearance procedure.

Scouring :

  • Unload anneal ovens and transport material to scour tank.
  • Scour material with appropriate cycle per specification.
  • Clean anneal ovens as needed.
  • Complete required information on the Device History Record (DHR) and other related forms.
  • Follow line clearance procedure.

Bulk Spooling:

  • Load racks onto bulk spooling equipment.
  • Create and verify tickets.
  • Thread fiber through required guides and onto spool.
  • Utilize HMI to select appropriate material and size.     
  • Start bulk spooling equipment.
  • Verify appropriate defect level at completion of spools. Complete required information on the Device History Record (DHR) and other related forms.
  • Follow line clearance procedure.

Cutting:

  • Inspect the quality of strands on racks. Identify, remove, and replace defective strands.
  • Cut remaining strands from racks.
  • Measure strand lengths.
  • Wrap strand ends together in predetermined amounts and label for subsequent processing.
  • Pull samples.
  • Verify labels.
  • Complete the Device History Record and other related forms using Good Documentation Practices.

Pack/Seal:

  • Use pre-formed foil pouches in accordance with the specification requirements. Verify the quality of pouches by performing the pouch tear down test. Record required data in logbook/form.
  • Produce required labels for expiration date.
  • Prepare foil pouches for loading with suture product.
  • Verify tickets and labels using a bar code scanner. Attach the label to the outside of each foil pouch or onto spools and cans.
  • Verify that paper drying oven has run per specification before unloading paper.
  • Load product into pre-dried paper folders per specification.
  • Place foil pouches containing product or spools of material into a Tenny oven and process per specification requirements.
  • Periodically check Tenny oven to verify cycle is running within specification.
  • After cycle is complete, heat seal the packages per specification or can spools per specification.
  • Verify the quality of the final seal and that the heat sealer is producing and record on appropriate form. Make sealing gasket and sealing bar changes to maintain quality of the seal.
  • Record all required data on the Device History Record and other appropriate logs/forms using Good Documentation Practices.
  • Follow Line clearance procedure.

Canning – Bulk Spools:

  • Check vacuum / Temperature / Time in Tenny oven to be canned
  • Turn on the canning equipment and ensure that the canner is operating per specification requirements.
  • Verify quality of the can seal. Perform vacuum testing to ensure integrity of the can seam.
  • Lube the canner at the required intervals and per specification.
  • Place the spooled suture material in a can, place lid in canner and complete canning cycle.
  • Package cans into shipping cartons and identify with appropriate labels.
  • Record all required data on the Device History Record and other appropriate logs/forms using Good Documentation Practices.

ADDITIONAL POSITION REQUIREMENTS

  • Work in team environment behaving in a CREDO based respectful manner.
  • Comply with all federally regulated programs.
  • Adhere to J&J environmental and safety policies and guidelines.
  • Comply with all job specific safety procedures and utilize PPE when necessary.
  • Comply with quality system requirements as defined within procedures and instructions.
  • Utilize applicable software systems as needed for the job (e.g. ComplianceWire, ADAPTIV, etc.)
  • Consistently meet required work performance targets (RE’s), if applicable
  • Support LEAN and Six Sigma Initiatives.
  • Lead Maintenance Excellence (ME2) activities including 6S and Operator Asset Care in the area.
  • Accurately complete records as defined within the job procedures (e.g. manual and/or electronic documentation).
  • Perform other work-related duties as assigned by supervisor.
  • Ensure adherence to current compliance regulations and standards in the department.
  • Ensure safe working conditions and practices in the department.
  • Cover for other operators during breaks, absences, leaves, vacations, etc.
  • Follow written specifications to manufacture products.

Kwalificaties

EXPERIENCE AND EDUCATION

  • High school diploma, G.E.D. or equivalent skills, experience, or training.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

  • Knowledge of all sub-functions of Monofilament Processor and Packaging Processor position.
  • Knowledge on use of test equipment (Starett Gauge, Mitutoyo Gauge, Microscope, Instron, etc)
  • Demonstrate teamwork in identifying, evaluating, and resolving problems within the department
  • Computer skills.
  • Excellent communication and interpersonal relation skills.
  • Problem solving.
  • General inspection skills.
  • Ability to use snips, scissors, copier, label making equipment, and scanner.
  • Ability to operate production and test equipment.
  • Accurate record keeping.
  • Basic math skills:  add, subtract, multiply, divide, average, rounding, percentages, tolerances.
  • Ability to calculate exposure time.
  • Ability to use snips, scissors, copier, label making equipment, and scanner.
  • Ability to operate production and test equipment.
  • Ability to consistently meet required Training due date targets.
  • Ability to train others.
  • Operation Certification required.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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