About The Position

The Quality Technician II plays a crucial role in ensuring product quality and compliance within a regulated manufacturing environment. This position involves guiding quality documentation, assisting with inspections and testing, and utilizing SAP for material movements. The technician will also review sterilization records, support change control activities, and assist in microbiology lab tasks, contributing to the overall quality assurance processes at BD.

Requirements

  • High School diploma or equivalent required; Associate degree in Quality, manufacturing or related subject preferred.
  • Two years of relevant experience in a regulated manufacturing environment preferred.
  • Knowledge of ISO standards, FDA regulations, and BD quality policies.
  • Proficient in using precision measuring instruments and computer skills (SAP, Excel, Word preferred).
  • Excellent communication skills, both verbal and written, with demonstrated problem-solving abilities.

Nice To Haves

  • Experience in a microbiology lab setting.
  • Familiarity with LAL (pyrogen test) within one year of hire.

Responsibilities

  • Provide guidance on product quality using appropriate quality documentation.
  • Partner with sterilization associates and Team Leaders to ensure proper handling of Quality Notifications in SAP.
  • Utilize SAP for product release and perform batch and run record reviews.
  • Comply with and enforce ISO Standards and FDA regulations as per BD procedures.
  • Assist with change control activities and support internal and external audits.
  • Prepare and sterilize culture media for microbiology testing and perform growth promotion testing.
  • Maintain accurate laboratory records and ensure rigid aseptic technique during testing.
  • Perform other duties as assigned by the Team Leader.

Benefits

  • Health insurance coverage
  • 401k retirement savings plan
  • Paid holidays
  • Professional development opportunities
  • Employee discount programs

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What This Job Offers

Job Type

Full-time

Career Level

Entry Level

Industry

Miscellaneous Manufacturing

Education Level

High school or GED

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