$90,000–$110,000 Per Year
Accreditation Standards, American Society for Quality (ASQ), Analysis Skills, Auditing, Biology, Chemistry, Communication Skills, Compensation and Benefits, Computer Vision, Conferences, Continuous Improvement, Corporate Compliance, Corporate Policies, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Customer Support/Service, Depth Perception, Detail Oriented, Disciplinary Action, Documentation, External Audit, FDA (Food and Drug Administration), FDA Requirements, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Industry Standards, Insurance, Internal Audit, International Electro-Technical Commission (IEC), Laboratory, Laboratory Management, Laboratory Operations, Leadership, Lift/Move 25 Pounds, LinkedIn, Maintain Compliance, Microbiology, Microsoft Office, Multitasking, Operational Improvement, Operational Strategy, Operational Support, Organizational Development/Management, Organizational Skills, People Management, Performance Management, Plan Meetings, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Process Improvement, Quality Assurance, Quality Management, Quality Metrics, Quality Monitoring, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Analysis, Root Cause Analysis, Safety Compliance, Safety/Work Safety, Sales Management, Staff Training, State Laws and Regulations, Strategic Planning, Team Lead/Manager, Time Management, Training/Teaching, Trend Analysis, Willing to Travel, Writing Skills
Quality Isn't Just a Standard, It's Our Foundation.
Join Tentamus California as a Quality Assurance Manager in Irvine and help ensure the accuracy, compliance, and excellence behind every result we deliver.
How you will contribute as part of our team:
The Quality Manager at Tentamus California is responsible for administering, overseeing, and maintaining the Quality Management System (QMS) to ensure compliance with applicable regulatory, accreditation, client, and company requirements. This role supports laboratory operations by promoting quality assurance initiatives, continuous improvement activities, and adherence to industry standards while fostering a culture of quality throughout the organization.
Reporting to Laboratory General Manager and Director of Quality Assurance responsibilities and duties include:
- Manage and maintain the laboratory Quality Management System (eQMS) in accordance with company policies, regulatory requirements, and accreditation standards.
- Timely cursory review and release of data to clients. This position is in charge of their departments communication with the rest of the laboratory on quality delays.
- Communicate with account managers and clients on delays of testing and outstanding issues and investigations.
- Ensure compliance with applicable FDA, ISO, GLP/GMP, CAP, CLIA, and other relevant quality and regulatory standards as applicable to laboratory operations.
- Develop, review, revise, and implement Standard Operating Procedures (SOPs), quality policies, forms, and controlled documents.
- Coordinate internal audits, external audits, inspections, and accreditation activities, including corrective action follow-up and documentation.
- Lead investigations related to non-conformances, deviations, complaints, and corrective/preventive actions (CAPA).
- Monitor quality metrics and trends to identify opportunities for process improvement and operational efficiency.
- Collaborate with laboratory management and department leaders to ensure quality objectives and compliance standards are consistently achieved.
- Provide guidance and training to employees regarding quality systems, regulatory compliance, and company procedures.
- Maintain document control systems, training records, and quality-related documentation.
- Participate in risk assessments, root cause analyses, and continuous improvement initiatives.
- Support client audits and respond to quality-related inquiries or concerns in a professional and timely manner.
- Ensure timely reporting, record retention, and compliance with company and regulatory requirements.
- Promote a culture of safety, quality, accountability, and continuous improvement within the organization.
- Establish procedures for maintaininghigh standards, reliability, and safety.
- Determine and enforce, through functional groups, quality requirements in accordance with real company needs, based on current regulations including ISO/IEC 17025, FDA and all other accrediting/ certifying agencies.
Supervisory Responsibilities
- Directly supervises Quality Department team members and responsible for hiring, performance management, and disciplinary actions.
Position Type & Expected Schedule
Full-Time, onsite at Tentamus California, Monday through Friday 10:00 AM to 6:00 PM with some weekend/holiday hours required depending on business needs.
To flourish as the Quality Assurance Manager, you'll need:
Our ideal candidate will be authorized to work in the United States indefinitely without restriction or sponsorship, possess a combination of technical skills, attention to detail, and a strong work ethic.Other qualifications include:
- Bachelor's degree in Quality Assurance, Chemistry, Biology, Microbiology, Life Sciences, or related field preferred.
- Minimum of 3 to 5 years of quality management or laboratory quality assurance experience preferred.
- Working knowledge of ISO standards, FDA regulations, GMP/GLP practices, and laboratory quality systems.
- Strong analytical, organizational, and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities and work effectively in a fast-paced environment.
- Experience conducting audits, investigations, and CAPA management preferred.
- Proficiency in Microsoft Office Suite and quality management software systems.
- Demonstrated experience ensuring compliance with regulatory, safety, and quality standards in an accredited laboratory environment.
- ASQ certificate preferred
What's in it for you?
Annual Salary between $90,000 to $110,000, comprehensive and low-cost benefit plans (medical with HSA option, dental, vision, disability, life insurance) Ample PTO,40 hours of sick time per CA state law, and a matching 401k.
Travel Requirements, Work Environment, & Physical Requirements
Travel Requirements
Light regional and national travel required up to 10 to 25% of the timeincluding overnight trips. Travel may include visits to operational sites,Client meetings,Industry conferences, Leadership meetings or strategic planning sessions. Ability to travel independently and reliably is an essential function of this role.
Work Environment
This position operates in a combination of professional office, laboratory, and field environments. Regular onsite presence is required to effectively perform the essential functions of the role.
Physical Requirements
While performing the duties of this job, the employee is regularly required to use hands and fingers to hold or feel, reach with hands and arms, talk, and hear. The employee is regularly required to sit at a desk working on a computer. Specific vision abilities include near distance, far distance, color, peripheral vision, and depth perception. Ability to lift up to 25 lbs.
About Tentamus:
Labs for Life. We are a global network of full-service accredited analytical laboratories providing crucial quality and safety analysis for clients locally, nationally, and beyond using proven methods of chemistry and microbiology. Many of the products you use and consume daily rely on Tentamus labs. With 20 labs in North America and growing (100 globally), we celebrate having talented diverse scientific and service-oriented professionals.
Visit us at Tentamus.com | Follow Tentamus on LinkedIn | Follow Tentamus CA on LinkedIn
Job Posted by ApplicantPro