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Instrumentation Laboratory - Bedford Production Operator, TEM - San Diego in San Diego, California

Instrumentation Laboratory

Our Passion. Your Results.

Founded in 1959, Instrumentation Laboratory (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, patient blood management and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing medical professionals the most valuable and complete solutions to enhance patient care.

As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostic products, IL is supported by significant resources, outstanding scientific expertise and a tremendous knowledge base. IL is headquartered in Bedford, MA, USA.

Position Summary:

The TEM Production Operator utilizes an array of production equipment as well as manual assembly to manufacture and package TEM products.

Key Accountabilities:

  • Assemble components of medical diagnostic devices in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs).

  • Perform in-process quality checks on sub-assemblies and finish products.

  • Identify line issues and other production problems; promptly notify Team Leader or Supervisor of all problems.

  • Support all efforts and procedures to maintain optimal manufacturing conditions.

  • Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs.

  • Maintain safe working conditions at all times; adhere to all safety policies and procedures.

  • Operate the following production equipment as directed and in accordance with all SOPs: Manual and semi-automated micro-fill.

  • Product recipe controller air-dry and freeze-dry chambers (load, unload, operate).

  • Various computer vision systems.

  • Manual and semi-automated in-process inspection.

  • Semi-automated tape, label, and barcode applicator machines.

  • Manual and semi-automated pouch printing (pre-setting for production).

  • Computer load printer (manual packaging and labeling by using final goods).

  • Materials handling for processing and packaging.

  • Ensure production areas are continually kept clean.

  • Continually work to achieve assigned production goals.

  • Prevent mix-up of products, materials, labels, and other components.

  • As directed, provide support for process and equipment validation.

  • Maintain daily product log books as directed.

  • Ensure and maintain compliance with the Company's quality system requirements through training and adherence to policies, procedures and processes.

  • Other duties as assigned.

Minimum Knowledge & Experience:

  • High school diploma or equivalent.

  • One (1) to two (2) years previous assembly/packaging experience; previous experience in a regulated medical device manufacturing or pharmaceutical environment strongly preferred.

  • Familiarity with GDP and GMP a plus.

  • Excellent hand-eye coordination needed. Basic written and verbal communication skills.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Instrumentation Laboratory appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

Werfen is a global leader in in vitro diagnostics (IVD) in the specialties of Hemostasis, Acute Care Diagnostics and Autoimmunity. Our core business is dedicated to R&D, manufacturing and distribution of diagnostic systems for hospitals and clinical laboratories. Our other areas of expertise include Original Equipment Manufacturing, Clinical Software, Clinical Chemistry, Infusion Therapy, and Medical Devices and Scientific Instrumentation Distribution.

We operate directly in over 30 countries and in more than 100 territories through distributors. In 2016, our turnover was approximately 1.2 billion euros and we had an average workforce of 4,400 people. Currently, we are over 5,000 employees.

Job ID: 2021-3773

Shift: 1st

Street: 6260 Sequence Drive