Descripción del Trabajo
Works under the direction of the Quality Assurance Organization and is responsible for providing support and leadership to the QA Team and the Sterilization Dose Audit Program to achieve quality, efficiency, and cost targets, while ensuring compliance to all applicable standards.
High school diploma or equivalent required.
University/Bachelor’s Degree or equivalent required, Microbiology preferred.
Six-sigma certification preferred.
KEY SKILLS/KNOWLEDGE REQUIRED:SKILL SETS
General knowledge of medical devices preferred.
Knowledge of Good Manufacturing Practices (GMPs) and ISO policy and procedures is preferred.
One or more years in microbiological laboratory environment or equivalent training.
One or more years in project management preferred.
KEY JOB RESPONSIBILITIES:
Provide leadership and execution for Sample Item Portions (SIP s) preparation, testing, documentation, reporting, and conclusions.
Provide leadership and execution for Environmental Monitoring Program (EM) for the Albuquerque Facility.
Provide leadership of activities and serve as a resource for quality issues and initiatives.
Provide coaching and mentoring of QA Technicians under the direction of the Quality Assurance Organization.
Coordinate with Manufacturing Operations to schedule and retrieve audit product samples on a timely manner.
Perform physical manipulation of product into SIP s under aseptic conditions.
Aseptically package and ship SIP s to testing laboratories.
Maintain Laboratory equipment and supplies for SIP s and EM.
Maintain accurate records verifying that required samples have been collected, processed and dispersed to appropriate testing laboratories.
Reviewing the incoming data for completeness and adherence to specifications.
Maintain communication links between different testing laboratories to ensure timely testing and accuracy of samples.
Create and Maintain laboratory procedures and governing documents.
Assist QA team with audits to assess compliance to GMP, ISO, and EES standards.
Support QA Team on a daily basis for SIP s and EM.
Coordinate and execute the EM Program, which includes but not limited to viable air and surface testing and no-viable air testing, also organism evaluation – morphology.
Compile and review EM testing results.
Coordinates discussions with Quality, Engineering, Operating Companies, Regional Lab Managers and other business partners to ensure department objectives are met.
Writes and executes protocols as necessary.
Performs complex tests and data analyses to recommend disposition of material.
Provide support as needed to manufacturing operations to determine the root cause of EM and/or SIP s failures.
Provide support to QA Team in continuous improvement activities as they relate to the education of product inquiries or other COGS initiatives
Maintain knowledge of all procedures, change to specifications (Process, Training Manuals, Material Specifications, etc.), and regulations related to their area of responsibility.
Maintain process knowledge for the assigned area of responsibility.
Works with QA Team on document and process improvements, including but not limited to data collection, ECN’s, and additional training as required.
Provide materials/communication or service to customers in a timely manner.
Recommends and implements revisions, corrections, and changes to test equipment, procedures, and methods.
Provide leadership and initiative to the QA organization through continuous improvement projects.
Provide necessary feedback to customers.
Coordinates discussions, written reports, and oral presentations with business partners regarding quality issues, projects, and activities as required.
Exercise initiative and ingenuity to deal with varying circumstances and changing conditions, referring unusual situations to QA Team.
Provide leadership with project completion and project enhancements.
Provide coverage and coordination for absences as required.
Provide leadership to team as appropriate.
Work cooperatively toward effective outcomes.
Work to resolve differences in a collaborative effort.
Follow all company safety policies and other safety precautions within the work area.
Promote safety to all associates that enter the work area.
Attend required safety training
Participate in implementation of the EMS management system including continual improvement, pollution prevention, objectives and targets, and regulatory compliance.
Implement and follow all applicable EMS procedures.
Adhere to the site’s EHS Code of Conduct.
Other responsibilities may be assigned and not all responsibilities listed may be assigned.
POST HIRE TRAINING PLAN REQUIREMENTS:
Maintain adherence to position training curriculum.
Training Plan Requirements as identified in Corporate Training Procedure, CP0128.
Applicable training plan for the area of support.
Requires long walking, standing, bending, stooping and reaching.
May require lifting of boxes or material not to exceed 50 lbs.
May require use of a pallet jack.
Maintain vision certification through the visual acuity testing/process.
Office deskwork, requiring sitting, walking, using the phone and computer
Operation of hydraulic and manual cutting equipment daily.
Work in office and/or manufacturing environment and/or laboratory environment.
Flexibility to adjust and rotate the working hours to support Laboratory needs.
Gowning required as per established procedures.
Little to no travel required. Passport may be required.
This description is representative of the knowledge, skill and ability necessary to carry out the requirements of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties of the job.