CHARACTERISTIC DUTIES AND RESPONSIBILITIES
- Ensure site compliance with applicable regulations such as CLIA, GxP, FDA etc., and monitors regulatory trends and development.
- Coordinate and lead client quality audits or regulatory inspections and develop audit responses.
- Perform/review assessments of suppliers/vendors, design/conduct supplier audits.
- Oversees the quality control (QC) program and develops new QC and data review procedures.
- Manages document control systems and SOP periodic review process, authors policy-level documents such as site quality manual, risk management manual.
- Design and oversight of change control program.
- Coordinate internal and external proficiency testing programs to verify the accuracy and reliability of test systems and ensure personnel competency.
- Oversee 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.
- Review QC trending reports from the QC Scientist and provide guidance for investigations and corrective actions when needed.
- Work with surveillance director and manager to design trending metric and perform data analysis to assure quality of reagents utilized in surveillance testing.
- Develop quality metrics and key performance indicators and present quality metrics at quarterly management review meetings.
- Author, review, approve validation documents.
- Authors QC reports for client studies, as needed.
- Design, monitor and review internal audits of studies and/or systems to assure integrity. Provide audit reports to senior management and/or study directors.
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.
Administrative and functional supervision is exercised over quality assurance staff, and over supporting professional technical and clerical staff.
- Requires 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.
- Prior experience in demonstrated audit responsibilities, including interactions with regulatory agencies such as the FDA, and responding to documented observations as needed.
- General understanding of applicable industry regulations and guidance documents and their application to quality within the laboratory.
- Previous supervisory or management experience is required, and ASCP/NCA certification is desirable.
- At least 5 years of supervisory or management experience, and reasonable knowledge of fiscal management is required.
- Demonstrated proficiency in communication fosters positive working relationships amongst staff.
- Strong attention to detail and exceptional follow-up skills.
- Strong initiative, sense of urgency, and commitment.
- Solid organizational and project management skills with the capacity to prioritize and multi-task.
JMI Laboratories is based in North Liberty, IA and offers a competitive salary and benefits package, which includes health, dental, vacation, 401(k) and profit sharing.
JMI Laboratories is an equal opportunity employer. No recruiters or agencies please.
To apply please submit your CV and cover letter.