Quality Operations Lab Technician

at  Johnson Johnson

JOB SUMMARY

The position of Quality Operations Lab Technician reports directly into the Senior Supervisor Quality Lab Operations. Ensures that systems within the Quality system are adequately maintained and back up activities for Senior. Quality Operations Lab Technicians and/or Senior Supervisor Quality Lab Operations as needed and requested from a broader scope within the Quality Management system and as defined in Roles and Responsibilities section of this document.

EXPERIENCE AND EDUCATION

MLO BOL/BBL 4 (minimum) in an analytical chemistry or microbiological direction.
HLO level preferable. Minimum of 2-4 years of related experience within Pharmaceutical and/or Medical Device companies. Knowledge of ISO: 13485

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Communication skills verbal and written (Dutch / English)
• High level of accuracy
• Flexible
• Service minded
• Stress resistant
• Good analytical skills
• Good planning skills
• Pro-active

Under and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• The Quality Operations Lab Technician performs laboratory routine testing;
• The Quality Operations Lab Technician sends out equipment for calibration and maintenance;
• The Quality Operations Lab Technician is able to create/implement specifications, forms and documents as needed to support day to day activities or projects under the guidance of the Sr QO Lab technician or the Quality Team Leader Inspection & Testing;
• The Quality Operations Lab Technician performs sampling activities;
• The Quality Operations Lab Technician is able to enter and check data in LIMS;
• The Quality Operations Lab Technician performs departmental projects;
• The Quality Operations Lab Technician when trained performs the identification of Non-conformances and generates NCR’s;
• The Quality Operations Lab Technician performs logbook data entry;
• The Quality Operations Lab Technician performs the inventory of lab supplies;
• The Quality Operations Lab Technician performs non-routine testing (validations, others as needed);
• The Quality Operations Lab Technician works on Yellow Belts (kaizen / Improvements);
• The Quality Operations Lab Technician performs Finished Device Testing;
• The Quality Operations Lab Technician performs test/LIMS verification or authorization;
• The Quality Operations Lab Technician performs RGA Evaluation;
• The Quality Operations Lab Technician performs control of the Q Cage including status labeling;
• The Quality Operations Lab Technician performs Incoming Goods inspection;
• The Quality Operations Lab Technician is authorized to stop a laboratory test;
• The Quality Operations Lab Technician has the ability to assist the Senior Quality Operations Lab Technician;
• The Quality Operations lab technician participates as needed in Production meetings representing QO Lab bases business;
• The Quality Operations Lab Technician supports Non-Conformances investigation as needed and defined bySenior Supervisor Quality Lab Operations;
• The Quality Operations Lab Technician is able to write forms and draft quality instructions (process specifications);
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Comply with all applicable environmental, safety and occupational health policies
• Performs other duties assigned as needed