Lab Quality Manager

Job Summary:
The Laboratory Quality Manager is responsible for overseeing and maintaining the laboratorys quality management system (QMS) to ensure compliance with regulatory standards, accreditation requirements, and internal policies. This role involves developing, implementing, and monitoring quality control procedures, conducting audits, managing laboratory certifications, and leading continuous improvement initiatives. The Laboratory Quality Manager works closely with laboratory staff, regulatory bodies, and clients to guarantee the accuracy, reliability, and safety of laboratory operations and results.Key Responsibilities:
Quality Management System (QMS) Maintenance:
Develop, implement, and maintain a comprehensive quality management system to meet regulatory, accreditation, and internal requirements.
Compliance Monitoring:
Ensure the laboratory complies with applicable standards such as ISO 17025, CLIA, CAP, GLP, or other relevant standards and regulations. Stay updated on industry changes and implement necessary adjustments to maintain compliance.
Internal and External Audits:
Assist with internal audits of laboratory processes and external audits by regulatory bodies. Ensure corrective actions are implemented and monitored.
Standard Operating Procedures (SOPs):
Develop and maintain up-to-date SOPs for laboratory operations. Ensure all staff are trained and adhere to these procedures.
Document Control:
Manage the document control process to ensure that quality documents (e.g., SOPs, audit reports, validation protocols) are reviewed, approved, and maintained in accordance with laboratory policies.
Training and Development:
Provide quality management training to laboratory staff and ensure they understand and comply with quality standards and protocols.
Non-conformance and CAPA Management:
Investigate non-conformance issues, oversee root cause analysis, and implement Corrective and Preventive Actions (CAPA) to prevent recurrence.
Quality Metrics and Reporting:
Develop and track key quality indicators. Provide regular reports on the performance of the QMS to management and recommend improvements.
Customer Complaints:
Address and investigate customer complaints regarding laboratory services. Ensure timely resolution and implementation of corrective actions as needed.
Risk Management:
Identify and mitigate risks related to laboratory processes, ensuring the highest quality and reliability of results.
Continuous Improvement:
Lead initiatives for the continuous improvement of laboratory processes, focusing on enhancing efficiency, reducing errors, and improving overall quality.
Laboratory Management:
The ideal candidate will have extensive experience in laboratory management, a strong understanding of quality management systems, and the ability to lead and inspire a team of laboratory professionals

Pay $40-45/hr

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Required Skills & Experience

Qualifications:
Education:
Bachelors degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field). Advanced degree or certification in Quality Management is a plus.
Experience:
Minimum of 5 years of experience in a laboratory setting, with at least 3 years in a quality management or supervisory role. Experience in a regulated environment (e.g., clinical, pharmaceutical, environmental labs) is preferred.
Skills and Competencies:
o Strong knowledge of quality management systems and relevant laboratory standards (e.g., ISO 17025, GLP, CLIA, CAP).
o Experience managing multiple workstreams simultaneously
o Experience with audit processes and regulatory compliance.
o Excellent problem-solving and analytical skills.
o Ability to manage multiple quality projects and deadlines in a fast-paced environment.
o Strong leadership and communication skills.
o Proficiency with quality management software and laboratory information management systems (LIMS).
Certifications:
o Certification as a medical technologist or medical laboratory scientist by the American Society of Clinical Pathologists (ASCP), AMT (American Medical Technologists) or AAB (American Association of Bioanalysts) according to the qualifications through the State of Georgia Department of Community Health, Healthcare Facility, Clinical Laboratory regulations.
o Certification in Quality Management (e.g., ASQ CQE, CQA) or equivalent is preferred.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.