QC Lab Technician II

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.

• Perform visual and analytical testing on incoming, in-process and finished goods, stability samples and product returns for compliance with established quality specifications, including pH, density measurement, spectrophotometry, gas chromatography.
• Perform environmental monitoring for RODI water system and Liquid Media manufacturing.
• Accurately document test results on QC reports, Stability Test reports, Offline Test Requests Validations and First Article Inspections as applicable.
• Analyze data to specifications and designate as accept/reject.
• Work with manufacturing, receiving and materials personnel to complete required QC testing, documentation in a timely manner.
• Perform out-of-specification investigations, troubleshooting, and other duties.
• Prepare standards and control materials. Maintain documentation of preparation.
• Ensure that equipment is cleaned and maintained according to work instructions.
• Maintain inventory to ensure QC lab reagents and supplies are ordered.
• Participate in continuous improvement activities (e.g. kaizen).
• Handle hazardous waste as appropriate.
• Maintain 5S of Quality Labs and Stability Chamber area when used.
• Additional responsibilities as assigned by Quality management.

• High School Diploma/GED.
• Minimum of 2 years’ experience in current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), or medical device Quality Assurance role. (Associate’s degree in quality, science, or engineering related field may be equivalent to 2 years’ experience), with a minimum of 3 years related laboratory experience.
• Experience with sampling techniques, inspection standards, or use of analytical laboratory equipment.
• Experience working in an FDA regulated environment (medical device or pharmaceutical industry).
• Demonstrated understanding in the use of calibrated equipment and ability to follow equipment maintenance repair procedures.
• Experience with SAP.
• Excellent math skills and the ability to utilize Excel for basic calculations and graphing.
• Must be able to speak, read, and write English fluently as well as write technically and summarize information into data reports using Microsoft Word.
• Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations.
• Excellent observation skills with a bias for “corrective action” and improve work environment processes and procedures.
• Demonstrated ability to make critical decisions regarding product quality or quality system compliance.
• Knowledge of basic validation, equipment calibration, equipment maintenance and changing requirements
• Proven capability to prioritize responsibilities and complete tasks on schedule.

• Knowledge of statistical techniques used in data analysis programs such as Excel or Minitab.
• Ability to correctly interpret and apply standard sample plans (e.g. American National Standards Institute (ANSI) or Statistical Process Control (SPC) charts) and use designated standards and controls.

• Up to 50% of the workday is spent standing.
• Must be able to work with hazardous chemicals and biohazardous materials in a safe manner.

• Position requires occasional overtime as designated by Operations/Quality management. Overtime duties may be outside of direct area of responsibility.
• 100% on-site work. Schedule may need to flex based on business needs. Position may require nontraditional work weeks such as 5 / 8-hour days.