A1C Quality Control Specialist

SUMMARY

The A1C QC Specialist is responsible for A1C Quality calibration testing and support for manufacturing, testing, functional operation and maintenance of any related production materials and/or equipment.  In addition, this position coordinates all blood management inventory, lab supply inventory, maintains calibration of reference analyzers and NGSP/IFCC program coordination.  This position will spend approximately 50% of their time performing A1C QC Tech testing in the lab and 50% of their time performing blood inventory management, lab supply management, reference analyzer maintenance and calibration and NGSP/IFCC program coordination.

ESSENTIAL DUTIES AND RESPONSIBILITIES

·         Perform Quality calibration testing/value assignment which includes running Total Hb, A1c whole blood Calibration, Temperature calibration, Accuracy bias, Initial lot release for Pilots /ICA and finished products and analyze the data accordingly.  

·         Make detailed observations, analyze data and interpret results.  

·         Maintain materials in working order and use calibrated equipment at all times.

·         Interact and cooperate with other personnel within the department and throughout the corporation in a professional manner.

·         Assists with whole blood sample preparation and inventory management for the department.

·         Maintains good laboratory procedures and practices, as well as ISO and QSR (GMP) requirements.

·         Adhere to all Safety Procedures as defined by OSHA and Site Safety policies especially those involving Chemical Hygiene, Hazard Communication and Blood borne Pathogens, which aids in a safe and organized working environment. 

·         Daily use of various computer programs including, but not limited to, MS Word and MS Excel for reporting and referencing purposes.

·         Responsible for maintaining adequate blood supplies for the lab which includes all aspects of the testing process.

·         Responsible for ordering and maintaining inventory levels of all lab supplies.

·         Responsible for calibration and maintenance of the A1C reference analyzers.

·         Responsible for NGSP/IFCC program coordination.

·         Other duties as assigned

QUALIFICATIONS 

·         Ability to use laboratory techniques.

·         Ability to follow written and verbal instructions & time management skills.

·         This position requires strong attention to detail.

·         This position may require irregular and extended hours of work, so the person hired must be capable of meeting the varied work hours 

·         Familiarity with methods for statistical experimental design and data analysis.

·         Working well in a team situation with others, scientific and nonscientific, is necessary.

·         Strong ability to maintain inventory levels with a structured approach.

·         Familiarity with reference analyzers.

·         Ability to work independently for all functions outside of the A1C QC Tech responsibilities.

·         Good verbal and written communication skills.

·         Project management skills preferred.

EDUCATION and/or EXPERIENCE

·         Minimum Associates degree in Chemistry/Biochemistry /Biology or related discipline (extensive relevant experience may be substituted).

·         Knowledge of IVD technologies is a plus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Employee works in multiple environments.  These include areas with mechanical equipment, moving parts, and laboratory chemicals.  Lab coat, safety glasses, and gloves is required while working in the laboratory setting.

EQUAL OPPORTUNITY EMPLOYER PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law.

QUALITY COMMITMENT

This position requires compliance to applicable quality system and regulatory requirements. This individual adopts a “quality in everything we do” approach to all aspects of the execution of responsibilities of this position. Through vigilance, this individual remains alert to any potential compliance situations, and must report such observations to managers and the Head of Quality.

STATEMENT of OTHER DUTIES DISCLAIMER

This Job description in no way states or implies that these are the only duties to be performed by this employee. This employee will be required to follow any other instructions and to perform any other duties requested by their supervisor.

PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service.