Quality Assurance Manager
Description

On Site

Flexible work hours upon request 

Requirements

Are you ready to lead a quality unit to ensure the safe and optimal administration of a leading microbiology and molecular laboratory that adheres to federal, state, and other regulations? Can you coordinate with internal and external stakeholders to review qualitative and quantitative data, design metrics, and ensure compliance with those guidelines? Do you feel comfortable assessing vendors, managing audits, and supporting the implementation of an eQMS system? If so, we welcome you to apply to be our next Quality Assurance Manager.  


DUTIES AND RESPONSIBILITIES

· Ensures site compliance with applicable regulations such as CLIA, FDA, and GxP and monitor regulatory development.

· Coordinates and leads client quality audits (onsite, paper, and virtual) or regulatory inspections and develop audit responses.

· Oversees assessments of suppliers and vendors, plus design and conduct supplier audits.

· Monitors the laboratory’s quality control (QC) program for compliance and help lead investigations and corrective actions.

· Manages document control systems and SOP periodic review processes and author policy documents such as the site quality manual and the risk management manual.

· Oversees eQMS implementation and maintenance while expanding its use to create efficiencies. 

· Coordinates internal and external proficiency testing programs to verify the accuracy and reliability of test systems and ensure personnel competency.

· Designs, monitors, and reviews internal audits of studies and/or systems to assure integrity, then provide audit reports to senior management and/or study directors.

· Supervises the deviation program, out of specification/out of trend (OOS/OOT) investigations, corrective and preventive actions (CAPA) program, and provide guidance for investigations and corrective actions.

· Works with the surveillance director and laboratory managers to design trending metrics and perform data analysis to assure the quality of reagents utilized in testing.

· Develops quality metrics and key performance indicators, then present quality metrics at quarterly management review meetings.

· Manages method and computer systems validation programs. 

· Provisions validations and review/approve documentation of compliance to regulatory criteria.

· Designs and oversee the change control program.

· Maintains audit plans and ensure site inspection readiness at all times.


SUPERVISION RECEIVED

The QA Manager is an independent function of the organization. The QA Manager receives guidance from the CEO/CSO if the same individual is not serving as a study director. 


SUPERVISION EXERCISED

Administrative and functional supervision is exercised over quality assurance staff and supporting technical and clerical staff.


QUALIFICATIONS

· Attained at least 5 years of previous supervisory or management experience.

·  Proficient at fiscal management (desired).

·  Awarded ASCP/NCA certification (desired).

· Achieved a bachelor’s degree in Clinical Lab Sciences or a related science field from an accredited college or university and at least 5 years laboratory experience, preferably in a quality control/quality assurance role in a regulated (GxP) or clinical environment or a master’s degree in one of the clinical laboratory science fields from an accredited college or university and at least 2 years laboratory experience, preferably in a quality control/quality assurance role in a regulated (GxP) or clinical environment. 

· Experienced audit manager, including facilitating interactions with regulatory agencies and responding to documented observations.

· Knowledgeable about applicable industry regulations and guidance documents and how they ensure quality within the laboratory.

· Able to foster positive working relationships amongst internal and external stakeholders by demonstrating excellent emotional intelligence combined with exceptional verbal and written communication skills that demonstrate attention to detail, initiative, and a commitment to timeliness. 

· Comfortable prioritizing and multitasking responsibilities due to strong project management skills. 


BENEFITS

JMI Laboratories is based in North Liberty, IA and offers a competitive salary and benefits package, which includes health, dental, PTO, LTD, and 401(k).

JMI Laboratories is an equal opportunity employer. 

No recruiters or agencies please.