Job Description Summary

The Quality Technician II supports the site by providing guidance regarding quality documentation/specifications, including helping with quality notifications, assisting with inspections/testing associated with validations and engineering studies and using SAP to complete material movements. The Quality Tech II will review sterilization run/batch records and assist in documentation and product investigation when discrepancies are detected. In addition, the Quality Tech II will assist with change control items and microbiology lab tasks and activities.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

• Give direction concerning product quality using appropriate supporting quality documentation.
• Partner with sterilization associates, and Team Leaders, to ensure Quality Notifications are handled properly and documented completely and accurately within the SAP system.
• Utilize SAP for product release.
• Perform batch and run record reviews and acceptance activities according to approved quality system documentation.
• Understand, comply with, and enforce ISO Standards and FDA regulations per BD procedures.
• Read, interpret, and explain specifications as required.
• Assist with change control activities as required.
• Ensure that all Safety, Quality and other BD policies, procedures and specifications are followed.
• Support internal and external audits as necessary.
• Perform backup change control/change coordinator activities.
• Assist with tasks and activities in the microbiology lab including:
  • Prepare and sterilize culture media for routine and experimental testing. Performs growth promotion testing and other media related quality control.
  • Obtains and prepares products, controls and laboratory supplies for sterility and other testing.
  • Assists with routine and experimental testing including, chemical testing, dose quality audits, pre-sterilization microbial load testing and bacteriostasis/fungistasis testing.
  • Maintains rigid aseptic technique during all laboratory testing.
  • Assists with maintaining accurate laboratory records related to job functions.
• Performs other duties as assigned by the Team Leader and required to support the needs of the business
• Obey all company policies, standards and rules, including but not limited to: Safety policies and rules (including lockout procedures); Quality policies.
• Must maintain regular, punctual attendance.

• High School diploma or equivalent, required.
• Associate degree (Quality, manufacturing or related subject), preferred.

• Two (2) years' relevant experience in a regulated manufacturing environment preferred.
• Previous Quality experience preferred.

• Knowledge of ISO standards, FDA regulations and BD quality policies.
• Proficient using precision measuring instruments.
• Excellent communication skills (both verbal and written).
• Demonstrated problem solving and decision-making skills.
• Must be able to learn the LAL (pyrogen test) within one year of hire.
• Excellent planning, organizational and prioritization skills.
• Able to work with minimal direction/supervision.
• Must be able to speak, read and write English
• Computer skills (SAP, Excel, Word preferred) - Basic

• PCP Level 2: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently. Requires walking or standing to a significant degree: or requires sitting most of the time but entails pushing and/or pulling of arm or leg controls.

• Indoor heated and cooled environment.
• May have intermittent exposure to chemicals.
• Safety glasses and safety shoes must be worn when in the sterilization and warehouse areas and as required in the microbiology lab.
• Some physical exertion, including lifting, may be required.

• All requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
• This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Associates will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.
• Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the incumbent will possess the abilities or aptitudes to perform each duty successfully.

• Must obey all safety rules.
• Must follow all QSR (GMP) regulations.
• Must cooperate fully with the safety and environmental program.
• May not pose a direct threat or significant risk to himself/herself or others.
• The "Essential Functions" and "Other Functions" listed in this description do not restrict the addition or deletion of any other responsibilities to this position.
• Management reserves the right to change all job descriptions without notice as business conditions dictate.
• All associates are expected to know and adhere to the Becton Dickinson Core Values which are:
  • We do what is right.
  • We thrive on innovation and demand quality.
  • We are accountable.
  • We learn and improve every day.
  • We help each other be great.