The Quality Specialist III is responsible for providing compliance and regulatory guidance support to all aspects of the organization.  This is performed by working closely with Clinical Lab, Lab Ops, BioPharma Services, Assay Development and Manufacturing Technical Transfer (MTT) departments. 

　　The Quality Specialist III’s main responsibility will be supporting the Clinical Lab (CAP/CLIA) by providing the quality activities required.  This position will support, audit and provide guidance to ensure GCP compliance with BioPharma Services for Clinical studies. 

　　The Quality Specialist III will participate in the supplier program and audit program (internal, external and 3rd party) by supporting or leading internal & 3rd party audits or performing external audits of vendors.  In addition, this role will process batch records, labeling & release of product, approve deviations, nonconformance reports, CAPAs, protocols and reports.

　　This individual is organized, self-motivated and have strong oral and written communication skills as they will work closely with internal customers to draft or revise documents and procedures. This position will work mostly independently to manage the day-to-day activities and priorities.

　　 ELEMENTS:

　　Education/Experience:  

　　B.S. or more in a related field

　　Minimum 5 years of experience in a Quality/QA function in a high-complexity clinical laboratory is preferred

　　Minimum of 5 years in a regulated environment (ex:  CAP, CLIA, Clinical Trails, FDA, or ISO lab) is preferred

　　Experience in electronic systems.  Trackwise electronic EQMS, DMS and TMS systems is a plus.

　　Experience in performing internal and external audits is a plus

　　  Communication Skill: Works effectively and independently with both internal and external audiences to analyze, interpret, and summarize data both orally and in writing.  Demonstrates the ability to write detailed protocols and procedures and SOP's, as well as draft detailed reports for internal and external communication of progress and results. 

　　  Interpersonal Skill: Works effectively and independently both as an individual and part of a team; can manage relationships with external “customers” effectively.

　　Judgment: Ability to proactively design and implement quality-related reviews and analyses; prioritize work and meet multiple deadlines, ability to work with a high level of independence.  

　　Execution: Highly efficient at multitasking; able to help the group set priorities to accomplish complex tasks; ability to troubleshoot problems and generate effective solutions.

　　ESSENTIAL FUNCTIONS: 

　　Operations Support

　　Responsible for review and approval of lot records, labeling of material and lot release for product stored at Room Temp (15-30⁰C), 2-8⁰C, -20⁰C and -80⁰C.

　　Responsible for review and approval of batch records for the processing of blood samples in the Clinical and BioPharma laboratories.

　　Providing troubleshooting guidance to the MTT or Lab Ops functions for issues that arise with material, testing methods, or equipment. 

　　Maintains accurate and detailed records in accordance with GLP, GMP, and GCP regulations.

　　Compliance Support

　　Participates and provides oversight on policies, procedures, monitoring, reporting, and improvement activities related to clinical guidelines, healthcare quality/safety initiatives, accreditation, and regulatory requirements (CAP, CLIA, CMS, CLS), in collaboration with Clinical Lab staff and leadership. 

　　Responsible for the Compliance program including assigning and approving Deviations, Nonconformance reports, CAPAs, Audits and tracking all action activities to completion.

　　Maintain standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, providing mitigations and immediately communicating these to management.

　　Providing guidance to the BioPharma Services, Assay Development, MTT & Lab Operations functions to ensure compliance with guidance docs and regulations (GCP, GMP, GLP, CAP, CLIA).

　　Performing Quality audits for the internal audit program, performing external audits (suppliers), and leading/participating in 3rd party audits by Sponsors.

　　Responsible for supporting the Supplier program and talking with Suppliers to resolve concerns.

　　Acts as coordinator and serves as point of contact for appropriate federal and state authorities and responsible for leading CAP accreditation inspections to ensure the lab meets respective standards, registrations, inspections and reporting for the Clinical Lab.

　　Monitors and schedule training and competency of Clinical Laboratory staff and support personnel to assure compliance with regulatory training including tracking due dates.

　　Quality System Management    

　　Generating, editing, and approving procedures, forms, and records, as necessary, to support the electronic Quality Management system.

　　Monitors and advises on the performance of the quality management system and departmental activities related to HIPAA compliance.

　　Analyzing Quality metrics, identify trends and present data to Quality Management and Management Review meetings.

　　Leads the quarterly Quality meetings by producing data, identifying issues or trends and reporting on performance against set indicators. Makes recommendations and identifies opportunities for improvements to leadership.  

　　Responsible for supporting a positive, professional, team-oriented, harassment-free work environment by understanding and complying with the Employee Handbook and Safety Policy/Manual and all Human Resources policies, and by demonstrating the Company’s values and being a role model for the Company Brand.

　　ADDITIONAL DUTIES:

　　May perform additional duties as assigned or directed by management from time to time.

　　  REQUIRED COMPETENCIES: 

　　Performance Orientation – Is driven by personal performance; achieves all objectives detailed in scorecards and comfortable with quantifiable assessments.

　　Impact Orientation – Performs to stated objectives and drives to make an impact on company goals and patients’ lives.

　　Competitive – Dedicated to a competitive spirit that supports Epic Sciences’ goal to be the premier CTC technology in the industry. 

　　Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.

　　Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.

　　Confidence - Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.

　　  PHYSICAL DEMANDS:  

　　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.  

　　While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. 

　　The employee must occasionally lift and/or move up to 25 pounds.

　　Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

　　Transition from standing and sitting often. 

　　TRAVEL: (less than 20%)  

　　This position may require some travel (domestic and international) to support Vendor audits and other functions as required.  

　　  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.

　　General office environment. Daily exposure to PCs and networks. 

　　The noise level in the work environment is usually moderate.

　　Disclaimer: 

　　The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. 

　　Epic Sciences is an Equal Opportunity Employer and committed to the principle of diversity

　　Salary range: $85,000-95,000 annually 

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