Quality Assurance Manager  (Full Time)

Position Overview:
The Quality Assurance Manager works with the Laboratory Management team to maintain and implement quality systems to ensure accreditation standards are followed, participates in internal and external audits, and ensure compliant document and event management.   

Required Education, Skills and Experience:

• Bachelor’s degree in science/engineering or a related field
• Build and maintain a Quality Management System
• Perform internal audits and work with external auditors
• Manage laboratory accreditations and certifications (CAP/CLIA)
• In-depth understanding of regulatory requirements (FDA, LDT, EUA, HC)
• Strong decision making skills
• Intrapersonal/human relations skills
• Ability to extract data from conversations and documents
• Maintain confidentiality
• Proficient computer skills with strong working knowledge in Microsoft Office (i.e. Word, Excel, etc.)
• Strong attention to detail, planning and organizational skills, and have the ability to work efficiently both in a team environment and independently
• Hands-on experience with authoring and managing quality documents and continuous process improvement.

 
 
Essential Functions/Responsibilities (other duties may be assigned):
Quality Management System

• Implementation of Quality Management Systems (e.g., documentation management, management of non-conformances, change management, and Corrective Action and Preventative Action (CAPAs)
• Maintains the quality program for the laboratory in collaboration with the laboratory management team
• Applies for and maintains laboratory licenses and accreditations
• Working knowledge of all accreditation standards including CAP/CLIA, and others as necessary
• Learns and maintains current, working knowledge of FDA and Health Canada regulations including those surrounding Laboratory Developed Tests (LDT) and Emergency Use Authorizations (EUA)
• Manages regulatory submissions
• Manages clinical trial submissions and documentation in collaboration with laboratory management and scientific leads
• Serves as a resource to the laboratory staff and facilitates comprehension of accreditation standards and regulations
• Prepares and delivers monthly Quality Assurance meetings
• Assures review of testing documentation such as Quality Control, Preventative Maintenance, and linearity
• Ensures proficiency testing is completed according to schedule; may assist management in analyzing data for shifts or trends
• Ensures competency assessments are completed on time. Achieves and maintains competence in all assays the lab performs
• Ensures documentation is completed on time and filed appropriately
• Assists in developing and maintaining Quality metrics
• Ensures quality issues and process problems are dealt with in a timely manner
• Reviews QIR’s and reports issues
• Communicate regularly with Executive Management
• Conducts internal audits, compiles reports stating improvement options for findings, implements improvement plans and follows up to assure improvements are successful
• Performs and contributes to quality metric analysis and compiles plans and recommendations based on findings
• Coordinates and manages CAP and alternative proficiency testing for the lab area in conjunction with laboratory management
• Investigates and documents all proficiency testing events in conjunction with laboratory management
• Assists and participates in accreditation inspections
• Event Management
• Works with the laboratory staff to identify events
• Works with the laboratory team to ensure events are investigated, documented and recommendations are followed

Document Management

• Maintains document management system
• Assists in writing and reviewing documents such as SOPs and training checklists to ensure document standards are met
• Ensures record storage and retention policies are followed

​New Products

• Manages new product validation events and timelines
• Manages tech transfer activities and regulatory submissions
• Assists in developing intended use claims
• Reviews marketing materials and patient report formats
• Ensures new products are fully validated prior to offer to include writing validation reports and analyzing results

Additional

• FLSA Status: Full Time, Exempt
• May require some work on nights and weekends

Please submit your resume and cover letter to [email protected]

StageZero Life Sciences, Inc. is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to gender, race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity/assignment, citizenship, pregnancy or maternity, protected veteran status, or any other status protected by applicable national, federal, state or local law.