QC Lab Technician II

Becton Dickinson; North Carolina; On-site; USD 42,000 - 54,000; Full time

Job summary

Waters is seeking a Quality Control technician for our North Carolina site. You will perform visual and analytical testing on incoming, in-process and finished goods to ensure adherence to quality specs, while documenting results and maintaining laboratory records.

The role involves data analysis, equipment maintenance, and collaboration with manufacturing to keep QC testing on schedule. Experience in cGMP/GLP in a regulated setting, SAP and Excel skills, and the ability to work both

Qualifications

• Minimum 2 years in cGMP/GLP or medical device QA in FDA-regulated setting.
• Experience with sampling techniques and analytical lab equipment.
• Ability to work with calibrated equipment and follow maintenance procedures.
• Strong documentation, data reporting and English writing skills.
• Experience with SAP and basic Excel operations for calculations.

Responsibilities

• Perform visual and analytical testing on incoming, in-process and finished goods for compliance with quality specs.
• Perform environmental monitoring for RODI water system and Liquid Media manufacturing.
• Document test results on QC reports and related stability/test records.
• Analyze data to specifications and designate as accept/reject.
• Collaborate with manufacturing, receiving and materials to complete QC testing timely.
• Perform out-of-specification investigations and troubleshooting.
• Prepare standards and control materials and maintain preparation records.
• Ensure equipment is cleaned and maintained per work instructions.
• Maintain inventory of QC lab reagents and supplies.
• Participate in continuous improvement activities (kaizen).
• Handle hazardous waste as appropriate and maintain 5S of lab areas.
• Contribute to regulatory and quality system compliance as directed.

Skills

Attention to detail

Excel

Strong math skills

Teamwork

Analytical thinking

Fluent English

Education

High School Diploma/GED

Associate's degree in quality/science/engineering

Tools

SAP

Minitab

Job description

Company Overview

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

• 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 nont