The Quality Assurance Manager will have overall responsibility for managing the company’s quality systems and monitoring studies to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are compliant with federal, state, or other regulatory requirements.

Key responsibilities include, but are not limited to:

• Manage the company’s quality assurance (QA) and quality control (QC) programs, and develop new QC procedures
• Manage document control systems and standard operating procedure (SOP) periodic review process, write SOPs, and review SOP revisions
• Manage the deviation program, out-of-specification/out-of-trend (OOS/OOT) investigations, and corrective and preventive actions (CAPA)
• Design and oversee change control program for laboratory process and data
• Coordinate internal and external proficiency testing programs to verify the accuracy and reliability of test systems and ensure personnel competency
• Write QC reports for client studies, as needed, and review final study reports for compliance with SOPs
• Review QC trending reports from QA staff and provide guidance for investigations and corrective actions, when needed
• Develop quality metrics and key performance indicators for different laboratory assays and maintenance of equipment, and present quality metrics at quarterly management review meetings
• Perform/review assessments of suppliers/vendors; design/conduct supplier audits
• Write, review, and/or approve validation documents
• Design, monitor, and/or review internal audits of studies and/or systems to ensure integrity
• Provide audit reports to senior management and/or study directors
• Coordinate and lead client quality audits and regulatory inspections; develop audit responses 

Required skills and knowledge:

• Bachelor’s degree in clinical laboratory sciences or a related science field
• 5 years of demonstrated laboratory experience, preferably in a quality-control or quality-assurance role
• 2 years of supervisory or management experience, preferably in a regulated (GxP) industry or clinical environment

Preferred qualifications:

• Functional expertise in CLIA, GDP, GLP, GCP, GMP regulations
• Working knowledge of method/instrument/system validation and 21 CFR Part 11 regulations, including electronic records, electronic signatures, and audit trails
• ASCP/NCA certification is desirable
• Excellent written, interpersonal, and verbal communication skills
• Detail-oriented with expertise in problem solving and solid decision-making abilities
• Knowledge of microbiology is desirable
• Proficiency in Microsoft Word, Excel, PowerPoint

This is an on-site position at our headquarters.

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.

If you want to contribute directly to help the world combat infectious diseases, we encourage you to apply. 

JMI Laboratories is an equal opportunity employer. No recruiters or agencies please.