At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.
Descripción del Trabajo
PURPOSE: Works under the direction of the Sterility 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.
Knowledge of applications of the Microsoft Office Suite - Word, Excel, PowerPoint,Outlook, Teams
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 sample item portions (SIPs) under aseptic conditions.
Aseptically package and ship SIPs to testing laboratories.
Maintain Laboratory equipment and supplies for SIPs 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 nonviable 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.
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.
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.
BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.