QC Lab Technician II

Job Description Summary

This position is primarily responsible for the day-to-day functional tasks required to maintain the QC laboratory, including management of lab inventory, production of in-house standards and controls, maintenance, monitoring and cleaning of lab equipment, and management of quality records generated by the QC Lab. This role is responsible for execution of analytical QC testing on applicable incoming materials, manufactured product, stability and validation testing, and any other investigational testing assigned. This role will perform environmental monitoring for RODI water system and Liquid Media manufacturing. This role is responsible for working within an established framework of compliance and developing and implementing improvements to product quality and the quality system.

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. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Job Responsibilities:

• 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.

Education and Experience:

• 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)

• Experience with sampling techniques, inspection standards, or use of analytical laboratory equipment preferred.

• Experience working in an FDA regulated environment (medical device or pharmaceutical industry) preferred.

• Demonstrated understanding in the use of calibrated equipment and ability to follow equipment maintenance repair procedures preferred.

• Experience with SAP preferred.

• Excellent math skills and the ability to utilize Excel for basic calculations and graphing preferred.

• Must be able to speak, read, and write English fluently as well as write technically and summarize information into data reports using Microsoft Word preferred.

• Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations preferred.

• Excellent observation skills with a bias for “corrective action” and improve work environment processes and procedures preferred.

• Demonstrated ability to make critical decisions regarding product quality or quality system compliance preferred.

• Knowledge of basic validation, equipment calibration, equipment maintenance and change requirements preferred.

• Proven capability to prioritize responsibilities and complete tasks on schedule preferred.

Knowledge and Skills:

Preferred Education / Experience / Skills:

• 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.

Physical Demands: (if applicable)

• Up to 50% of the workday is spent standing.

• Must be able to work with hazardous chemicals and biohazardous materials in a safe manner.

Work Environment: (if applicable)

• 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 4 / 10-hour days.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers 

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. 

#earlycareer

Required Skills

Optional Skills

.

Primary Work Location

USA NC - Mebane

Additional Locations

Work Shift