QC TECH FOR GROWING MEDICAL DEVICE COMPANY

International Technidyne Corporation, located in Edison, NJ, is a world leader in development and manufacturing of Point-of Care blood coagulation diagnostic systems. We are committed to developing, manufacturing & marketing safe, easy to use, & reliable products that are used by doctors, nurses & medical practitioners where care is provided to patients.  We currently have an opening for a QC Technologist .

 

SUMMARY:

Responsible for the execution of a broad range of bench test procedures used in raw material qualification, testing of finished goods prior to release, the investigations of product performance and conducting routine validation studies. This individual is responsible for these functions as well as for routine maintenance of the QC laboratory.  This individual works with the QC/QA staff to resolve product performance issues and maintenance of the documentation files of approved QC Standard Operating Procedures in compliance with ISO 9001/EN46001 and EN/ISO 13485 standards.  This individual may also be required to train or oversee laboratory technicians.

 

DUTIES/RESPONSIBILITIES:Technical

 

Assign Quality Control staff members as needed, and participate as required, to maintain the operation of the department with relationship to:

 Perform testing of biological raw materials and finished goods per relevant SOP and release of acceptable product.Perform testing as required for product validation and process validation on existing products and prepare reports.Perform testing as required for investigation of non-conforming material and performance evaluation and prepare reports.Maintain proper laboratory housekeeping and supply levels in the QC laboratory.Coordinate and perform testing as required on various special projects (LSR, RE, etc.) as deemed necessary by technical review team, and prepare reports.Other duties as assigned. Administrative

 

The individual must ensure that all administrative duties are executed in a timely and complete manner, including:

 Documentation of all test results and maintenance of product release records, including electronic records.Perform batch record audits as required under standard QA procedures.Ensuring the laboratory is always equipped to handle routinely scheduled testing and anticipated increases in test schedule.Documentation of existing product/process validation test results and maintenance of validation test results, including electronic records.Product testing database and performing relevant statistical analyses including trend analysis.Ensuring optimal laboratory supply levels and optimal laboratory equipment operation in the QC laboratory.Work with Technical Services, QA, Manufacturing, R&D, Clinical Affairs and Marketing as required to investigate and resolve non-conforming material and performance issues.Other duties as assigned.

 

EDUCATION AND EXPERIENCE:

GeneralMust have a BS/BA degree in natural scienceMust possess laboratory experience.Proficiency in computer skills required. Must have a basic understanding of Good Laboratory Practices and the ability to learn, understand and maintain FDA-GMP/QSR and ISO standards for quality.

 

SpecificBasic phlebotomy skills are importantMust have solid communication skills, good inter-personal skills and a strong ability to pay attention to detail Must possess laboratory dexterity, have the capacity to understand laboratory practices and QSR regulation.  Must have the ability to learn core programs, such as PeopleSoft and statistical programs.

 

We offer an excellent benefits pkg. including medical/dental, 401K & tuition reimbursement. EOE M/F/D/V. Email resume with salary requirements to: HR@itcmed.com