QC Lab Technician II

Regulatory Jobs; Mebane (NC); On-site; USD 42,000 - 54,000; Full time

Job summary

Waters Corporation in North Carolina (Mebane) is seeking a Quality Control Lab Technician to perform visual and analytical testing of incoming, in-process and finished goods in a regulated environment. You will document results, support environmental monitoring, and participate in continuous improvement projects while maintaining 5S and proper waste handling.

The role requires at least 2 years in cGMP/GLP or medical device QA, proficiency with Excel and SAP, and the ability to work independently

Qualifications

• 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.

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.

Skills

Attention to detail

Excel proficiency

Math skills

English fluency

Independent worker

Teamwork

Decision making

Education

High School Diploma/GED

Associate degree in quality/science/engineering

Tools

SAP

Excel

Minitab

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

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.

Job Description

Job Description

• 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), 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.

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:

• 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

• 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.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

Optional Skills

Primary Work Location

USA NC - Mebane

Additional Locations

Work Shift

US BD 1st Shift 8am-430pm (United States of America)