Calibration Supervisor
Location:
Horseheads , New York
Posted:
April 02, 2017
Reference:
2690170215-en-us

DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and well being of people around the world.

 

 

Under minimal direction performs all responsibility necessary to provide oversight to the Site Calibration Program which includes; Master Data development and entry, calibration program development and execution, internal and vendor training, calibration equipment management and vendor management.  Able to provide direction and make decision within the scope of the role and responsibility for a variety of tasks included but not limited to quality and compliance, technical management in regards to monitoring the process and equipment calibration performance, make decision for  adjustment of the process to improve throughput and product quality. Responsible for developing, maintaining and communicating the maintenance plan & working with the equipment owners and maintenance lead(s) to ensure the work is done when required. Accountable for executing short-term production objectives ensuring proper and compliant utilization of manpower, equipment and raw materials.  Provides input in developing strategy and departmental business plan.  Develop recommendations and implement approved solutions to assigned projects. Responsible for achieving day-to-day process outcome and delivering metrics for the process. Provide leadership to ensure adherence to all safety, environmental and quality policies and procedures.  Acts as a leader for planning and scheduling activities and the management of the calibration program and fills in for US Calibration Manager when necessary.

 

 

POSITION DUTIES & RESPONSIBILITIES:

 

Ensure quality and compliance in all my actions by:

• Attend GMP training on the schedule designated for my role and as appropriate for my role.

• Adhere to strict compliance with procedures applicable to my role.

• Exercise the highest level of integrity in the tasks that I perform.

• Work with the team to ensure all aspects of the business remain compliant and in an audit ready state.

• In a timely and prompt manner, identify report and seek correction for deviations noted in my workplace.

• Embrace a behavior of employee involvement and commitment to doing the job right the first time.

• Manage continuity of supply resulting in achievement of company customer service targets

 

Equipment Set up, Start up checks, Trouble shooting, and repair.

• Be the point of contact for Laboratory, Utilities and Operations calibration program.

• Set up the Master Data for the Calibration Program. 

• Approve all calibration work order execution, as required.  Ensure all calibrations are executed on time. 

• Develop and implement a calibration system that meets the Quality Standards and utilizes Mean Time To Repair, Mean Time Between Failure, Failure Mode Effect Analysis, Criticality Assessment and other good calibration practices for the site.  Develop and implement metrics to measure the calibration program execution.  Use process excellence tools to optimize the calibration program.

• Work in collaboration with the Engineers, Calibration Technicians, System Owners and QA in conducting Root Cause Failure Analysis (RCFA), recommend, implementing and monitoring corrective actions for equipment failures and critical system/process failures and utilize analysis and trending techniques to support continuous improvement in the cost of operating and maintaining site assets.

• Setup equipment as per procedures to ensure proper operation.

• Follow environmental health and safety procedures during setup and operation of equipment.

• Adjust equipment plans and frequencies to optimize performance.

• Troubleshoot equipment problems with instrument techs to minimize downtime.

• Works with engineering to develop and implement equipment information and PM’s.

• Manage continuity of supply resulting in achievement of company customer service targets

 

Equipment Cleaning & Housekeeping

• Maintain metrology/calibration equipment orderly and ensure vendor area is maintained orderly.

 

Calibration

• Lead the storage, maintenance and asset care of the calibration equipment.  Lead calibration (transactions, conducting, and closing) including Gage Insite activities.  Report deviation and escalate to management. Support deviation and non-conformance investigator.  Perform required check/sampling and testing as per batch record and standard operating procedure directives.

• Maintain the ongoing-specific training and assessment of the calibration technicians

• Lead the criticality instrument analysis, maintain the calibration procedures, calibration records, calibration standards

• Participate as the site lead for vendor selection and auditing 

 

Systems Knowledge

• Be a Power User in the applicable systems and roles assigned.

• Trained to the role in which you are assigned as required for your job function in the applicable systems.

• Utilize tools within MS office and other systems to improve business effectiveness.

• Exposure to & working knowledge of electronic batch records and/or other automated processes/systems (labs).

• Working knowledge of CMMS systems; including other relevant systems per role.

• Working knowledge of an automated system.

 

Product Knowledge

• Be the calibration SME to understand the critical aspect of product , component and labeling requirements. Point of reference for Audit and acts as SME

 

Training

• Partner with training department to create training materials.

• Can act as qualified trainer in specific areas.

• Participate in all trainings.

• Ensure all trainings are completed on-time.

 

Investigations

• Assists in gathering information and documentation as required.

• Participates in and writes investigations as required.  

• Can act as approver on investigations. 

 

Compliance- Safety, GMP, Facilities

• Ensure employees under scope of responsibility are trained in required procedures for execution of their role and maintain current with training requirements during the year.

• Promote an environment of employee involvement in the workplace.

• Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.

• Extracts, enters all commitments from regulatory documents, internal audits into the commitment tracking systems.  Monitors and follows up for ensuring timely completion of all commitments.

• Attend GMP training on the schedule designated for the role and as appropriate for the role.

• Adhering to strict compliance with procedures according to the roles and responsibilities.

• Exercises the highest level of integrity in the tasks performed.

• In a timely and prompt manner, identify, report and seek correction for deviations noted in the workplace.

• Embrace a behavior of employee involvement and commitment to doing the job right the first time.

• Strong working GMP knowledge. Communicates and identifies GMP gaps.

• Participate in and act as SME in all types of audits & Inspections.

• Responsible for ensuring all areas and operations (processes) are completed in a compliant and safe manner.

• Coordinates efforts in case of emergency- spill, fire etc.

• Takes necessary action to eliminate and immediately address safety hazards. Communicate any observed unsafe behaviors immediately.

• Understands the safety concerns and promotes a safety conscience culture for their job function.

• Wears the appropriate PPE when working in manufacturing and other hazardous working environments and advocates standards of safety.

• Contributes and attends all EHS programs as assigned.

• Promptly communicates deficiencies to management.

• Maintains facility and work area in good working condition.

• Works with team to ensure all aspects of business remain compliant.

 

Documentation Management

• Approve SOP and relevant quality documentation. SME and responsible for review and sign off of relevant documentation per the function (i.e. mfg) as required by the quality process in the execution of the relevant work.

• Edits and authors documentation (i.e. Standard Operating Procedures, work instructions) as necessary.   Identify opportunities to improve procedures and assist in revisions.

• Perform/assist in the completion and documentation of the process steps as per the documentation directives.

• Complete documentation of maintenance activities in the appropriate system.

• Document all activities per the GMP requirements.

 

Business Transformation, Lean, ME2

• Completes PE/ Lean awareness training.  Ensure that team actively participates and applies learning's from training.

• Proactively identifies, evaluates, and prioritizes, opportunities for continuous improvement.  Facilitates team identification of these opportunities.

• Drives implementation of continuous improvement actions and kaizen events.  Acts as a champion for PE / Lean methodology and application of Lean concepts in work area.  Supports team in application of lean concepts and methodology.

 

Leadership

• Job expert that less experienced personnel can go to for assistance

• Act as a mentor and coach in functional area

• Provides leadership in absence of supervisors (for short periods).

• Assist management through change and transformation activities.

• Facilitates departmental meetings and may assist in the coordination of  other scheduled meetings. In absence of management, attends meetings on his/her behalf.

• Acts as  a role model when continuously demonstrating all GLP values; specifically:  integrity and credo based actions, self awareness and adaptability, results and performance driven, organization and talent development, and collaboration and teaming.  Demonstrated behaviors include:  fairness, honesty, consistent and ethical behaviors, empathy and collaboration.                                                                                                                                                                     

• Acts as a role model when exhibiting core values and behaviors.

• Fosters a climate of open communication, engagement and ownership within team.

• Builds cross-functional working relationships.

• Provides feedback to site management.

• Supports strategic and tactical plans in alignment with site's mission and plans.

                


Qualifications

• A minimum of a Bachelor’s degree in Engineering, Science, or Business is required.

• A minimum of 4 years of experience in a medical device and/or pharmaceutical industry is preferred.

• Must have previous professional Calibration experience

• Must be able to work on multiple projects with accelerated timelines.

• Excellent organizational skills and attention to detail is required.

• Excellent computer, communication, and written skills are required.

• Proficient in Microsoft WORD, Excel, and PowerPoint required.

• Demonstrated results in manufacturing maintenance operations.

• Knowledge of FDA, EMA and cGMP regulations.

• Demonstrate ability to interact, motivate and lead individuals in a manufacturing environment.

• Demonstrate analytical skills, process and data driven orientation, the ability to effectively resolve technical issues is required.

• Knowledge of company, industry, and regulatory standards and data-based decision to include root cause analyses, cost/benefit, and risk assessment.

• This position will be based in Elmira, NY and requires up to 25% travel
Primary Location
United States-New York-Horseheads
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality (Generalist)
Requisition ID
2690170215

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