Laboratory Quality Specialist

Overview

The Quality Specialist plays a vital role in the operations of the clinical laboratories in states where Unified Women’s Healthcare has laboratories under the direction and guidance of the Vice President of Laboratory Operations. The Quality Specialist will champion various aspects of the Quality Management Program such as facilitating resolution of non-conforming event management, ensuring compliance with regulatory requirements, and harmonizing practices amongst all Unified Laboratories.

Responsibilities

• Supports development, implementation, and monitoring of improvements to the Quality Management System.
• Provides support to regional laboratories in proactive resolution of quality issues and complaints, root cause analysis and troubleshooting as well as CAPA determinations for nonconforming events and follow-up.
• Aids in planning and preparing for state, federal, and CAP accreditation inspections and assists with inspection readiness efforts.
• Drafts various SOPs and other documents and provides training to appropriate staff.
• Performs administrative functions in the laboratories’ electronic Document Control System in MediaLab.
• Coordinates document control activities and documentation of staff training.
• Assists with coordination of Proficiency Testing program for each laboratory.
• Conducts internal quality audits and documents findings.
• Aids with standardizing process, practices and documents across all laboratories.
• Stays up to date on regulatory requirements and guidance and enhances and maintains a company knowledge of relevant regulations and guidance (CAP, CLIA, CLSI, OSHA, HIPAA, etc.).
• Assists in developing and maintaining laboratory-based metrics to measure efficacy of the QMS (e.g., status of document control, employee training, quality audits, corrective actions) and provides visibility for management oversight.
• Delivers presentations in a professional manner with all levels of staff.
• Ensures quality and compliance procedures are followed across all laboratories.
• Maintains effective working relationships and communication across all the Unified Laboratories.
• Follows all company safety policies & other safety precautions within the work area.
• Performs other quality assurance tasks as assigned by manager.

Qualifications

• Bachelor’s degree with a preferred emphasis in medical technology, chemical, or biological science.
• One or more years of clinical laboratory experience with knowledge of CLIA regulations, CAP requirements, and CLSI guidelines is preferred.
• Ideal candidate to have experience with anatomic pathology testing platforms including gynecologic cytology, histology and/or molecular, preferably in women’s health.
• Strong background in gynecologic cytopathology statistics and cytology quality management preferred.
• Knowledge of applicable regulatory and accreditation standards, rules, and guidelines.
• Strong skills for organization, planning, decision-making, and facilitating process improvement.
• Exceptional communication skills / professional presence with ability to lead and drive change.
• Strong customer orientation and ability to foster long term customer relationships.
• Ability to create and maintain trend charts supporting, monitoring, and measuring activities.
• Extremely detail oriented and committed to high quality.
• Experience working in a fast-paced laboratory environment.
• Hands-on experience with MediaLab is a plus.
• Audit experience and certification is a plus, such as ASQ or Six Sigma.

We’re here for you—both personally and professionally. Our benefits are designed to support you and your family at every stage of life. From health and wellness to financial security and career growth, we offer a comprehensive package to help you thrive. Here’s a look at what we offer:

• Health Coverage

Medical, dental, and vision plans, fertility benefits, and supplemental insurance options.

• Paid Time Off

Vacation, personal days, and paid holidays to help you recharge.

• Financial & Retirement Planning

401(k) with employer contribution, plus Flexible Spending Accounts (FSAs) and Health Savings Accounts (HSAs).

• Income Protection

Short- and long-term disability, paid parental leave, basic life insurance, and optional additional coverage.

• Wellbeing Support

Employee Assistance Program, commuter benefits, pet insurance, and identity theft protection.

• Professional Development

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