The Quality Assurance / Compliance Manager is responsible for developing, implementing, managing and coordinating all functions of Quality Assurance, Compliance and Quality Management efforts at the International Genomics Consortium. This includes pathology, histology, and molecular analysis as well as support departments. The Manager champions the development and monitoring of quality improvement initiatives, quality metrics and corrective and preventative action. The manager is the representative for the Quality Assurance department to both internal and external functions.   

ESSENTIAL FUNCTIONS:

1.      Coordinates Quality Assurance / Compliance program with all department supervisors.

2.      Ensures compliance with federal and state laws and regulations specific to safety and laboratory testing procedures and results.

3.      Ensures OSHA regulations are followed.

4.      Manages facility-specific activities and operations in Quality Assurance, the Quality Management System and state licensure.

5.      Maintains the Quality & Safety Manuals and associated Quality & Safety Procedures and all appropriate training and communication related to them.

6.      Develop and coordinate overall site quality and business metrics and department specific metrics.

7.      Develop reports summarizing metrics and results for both internal and external leadership.

8.      Manages the Corrective and Preventative Action (CAPA) and Annual Quality Improvement Plans.

9.      Manages internal and external CLIA audits.

10.  Ensure an effective Document Control system is in place.

11.  Prepares and delivers training on safety, compliance, and or quality management tools to management and staff as needed.  

12.  Champions Quality Improvement Initiatives.

13.  Represent quality assurance on TCGA project-wide Quality Management System working group.

14.  Ensure Training and Competency requirements are defined and achieved.

15. Other duties as assigned. 

PHYSICAL/MENTAL DEMANDS/ENVIRONMENT:

Requires the ability to work independently, make decisions, speak clearly, read and write in English, manual dexterity, sit for long periods, ability to coordinate information and activities, ability to prioritize and manage multiple projects simultaneously, perform mathematical calculations, ability to function in a fast paced environment, meet critical deadlines, customer service oriented and projects a positive interaction with outside agencies.

EQUIPMENT USED:

Computer, laser printer, scanner, copy machine, calculator, fax machine, general office and specialized software, general office equipment, laboratory equipment and freezers.

MARGINAL/ADDITIONAL FUNCTIONS:

Other tasks in support of overall project operations as assigned by senior IGC leadership.  Maintains regulation knowledge through publications, journal subscriptions, and a proactive educational approach to compliance needs.

SUPERVISORY RESPONSIBILITIES:

            Direct Reports: NA – Additional staff may be added as needed.

            Indirect Reports: NA

            Scope of Supervisory Responsibilities: NA

MINIMUM QUALIFICATIONS:

Minimum BS/BA degree in laboratory science or other related field; Ph.D. in laboratory science or related field preferred.

·         Current Clinical Laboratory Scientist (CLS) license preferred.

·         Demonstrated knowledge of CLIA preferred. 

·         Demonstrated knowledge of OSHA.

·         Minimum of 3 years experience in Quality Assurance and Compliance or a similar environment.

·         3 Years demonstrated leadership and management responsibilities.

·         Excellent written, verbal and presentation skills.

·         Cross-functional team facilitation skills.

·         Experience working in a team environment a plus.

·         Six Sigma and/or Process engineering experience is a plus.

·         Membership in Society of Quality Assurance (SQA), American Society of Quality (ASQ) or other related association preferred.

·         3 years of Quality Management Systems (QMS) experience.