Quality Control Technologist (Manufacturing)
Diagnostica Stago, Inc., (DSI) is an industry leader in the science of hemostasis and thrombosis. Stago provides the total commitment of global resources and responsiveness, coupled with cutting edge technology and reliability. DSI is dedicated to continually developing and providing the very best hemostasis products, technical support, and services.
The Quality Control Technologist is responsible for performing and managing all quality control testing on in-process and finished products. This includes executing laboratory procedures, analyzing data for trends and stability, and ensuring compliance with regulatory standards. The QC Technologist plays a key role in maintaining product quality, supporting product release, and driving continuous improvement.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Perform QC Testing: Independently conduct routine and non-routine quality control testing on raw materials, in-process samples, intermediates, finished products, and stability/lot verification samples in accordance with SOPs.
- Data Analysis & Documentation: Analyze and interpret test results using statistical tools; document findings accurately following Good Documentation Practices (GDP).
- Planning & Scheduling: Plan, prioritize, and schedule QC activities to ensure timely testing in alignment with business needs and production timelines.
- Inventory & Materials Management: Maintain laboratory inventory of reagents, controls, and supplies; inspect and verify incoming materials and finished goods to support material release and testing continuity.
- Equipment & Compliance Oversight: Manage calibration schedules and equipment compliance to ensure all instruments are maintained according to regulatory and operational standards.
- Quality Investigations: Support and participate in quality investigations, including deviations, non-conformances, and customer complaints, in collaboration with QA/RA and other departments.
- Collaboration & Continuous Improvement: Work closely with cross-functional teams to support routine operations and assist with process improvement initiatives led by the Product Development Scientist and Supervisor. Assist in manufacturing and packaging tasks ( e.g capping / stoppering) as needed
- Train QC Technologist Assistant, ensuring adherence to QC protocols and best practices.
Qualifications
- Bachelor's degree in related field (e.g. Biology. Chemistry, Medical Laboratory Science) from four-year college or university required with one to two years related experience. MLT/MT required/MT preferred. Or Bachelor's degree in related field required with one to two years DSRV specific QC related experience and/or training .
- To perform this job successfully, an individual should have proficient knowledge of Microsoft Office (especially Excel and Word).
- Ability to read and comprehend standard operating procedures, short correspondence, and memos.
- Capable of writing clear, concise documentation and simple correspondence.
- Able to effectively communicate information in one-on-one and small group settings with colleagues across departments.
- Proficient in basic arithmetic, including addition, subtraction, multiplication, and division using whole numbers, fractions, and decimals.
- Able to calculate reagent and control requirements for annual usage, including applying rounding rules per internal procedures.
- Demonstrated ability to perform basic statistical calculations, including mean, standard deviation, and coefficient of variation.
- Strong practical judgment and ability to follow written, oral, or diagram-based instructions with accuracy and consistency
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
We offer an extensive benefit and compensation package that includes medical, dental, vision, FSA, 401k, PTO, life and disability insurance, as well as a comprehensive leave program. Pay anticipated for this position in New Jersey is from $68,000-88,000 depending on a number of factors. This role is also anticipated to be eligible to participate in a bonus plan associated with this position. In the ordinary course of business, compensation and benefits programs may change based upon the Company's needs.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
