Job Description Summary

Job Description

PRIMARY DUTIES AND RESPONSIBILITIES

• Provides effective leadership to achieve high levels of service product quality financial results and other criteria in accordance with policies goals and objectives.
• Fosters a culture of collaboration accountability and continuous improvement emphasizing employee involvement empowerment and professional growth.
• Leads the transition to a fully automated laboratory ensuring integration of automation with testing equipment and workflow processes.
• Develops and implements strategies to optimize automated workflows enhance efficiency and maintain high-quality standards.
• Hires supervises trains develops and evaluates performance of assigned personnel; manages staff development performance improvement investigations and performance management.
• Leads and motivates managers supervisors and team members.
• Communicates new and revised enterprise policies and procedures to team members ensuring timely and accurate implementation.
• Assists in the development and implementation of the strategic plan for the laboratory establishing objectives and procedures governing performance.
• Ensures team members are trained and comfortable with automation systems and can troubleshoot manage and enhance automated processes.
• Leads organizational excellence initiatives (e.g. stakeholder meetings kaizens Gemba walks process improvements process mapping).
• Participates in enterprise-wide activities and teams to assure organizational excellence and alignment.
• Directs all laboratory operations including sample management donor testing support services and equipment maintenance.
• Ensures compliance with internal SOPs external regulations (FDA CFR CLIA AABB OSHA Workers Compensation) and company policies.
• Performs duties delegated to the CLIA Technical Supervisor to ensure regulatory compliance.
• Leads or participates in management team meetings regulatory/client inspections and internal/external audits.
• Assists in the design planning construction and alteration of facilities including project management tracking and timelines.
• Oversees laboratory equipment including validation maintenance quality control trending and repairs.
• Assists with the implementation and maintenance of the Quality Assurance Program for the laboratory.
• Reviews statistical information test data quality control incident reports and deviations; recommends and ensures completion of corrective actions.
• Oversees the implementation of new clients assays equipment and software at the local facility.
• Provides oversight of the Environmental Health and Safety (EHS) program for assigned facilities and provides EHS program coverage as needed.
• Assists with the preparation and implementation of annual operating and capital expenditures budgets.
• Reviews ongoing cost analyses of all test services and laboratory operations to ensure operational efficiency and identify anomalies or trends in the data.
• Performs all other duties at the discretion of management as assigned.

REQUIRED QUALIFICATIONS

• Education: Bachelors Degree in a related area required
• Experience: Minimum 8 years of relevant laboratory experience including at least 5 years in progressively responsible leadership roles
• Experience with high-volume laboratory production
• Knowledge of federal state and local regulations as they relate to laboratory operations
• Working knowledge of management processes (planning budgeting organizing implementation)
• Must satisfy CLIA requirements for High Complexity Testing

PREFERRED QUALIFICATIONS

• Masters degree
• Experience with laboratory automation
• MT ASCP (or equivalent) Specialty Certification
• Trainer Certification
• Certifications as required by applicable states

SKILLS & ABILITIES

• Must possess the skills and abilities to successfully perform all assigned duties and responsibilities
• Must be able to maintain confidentiality
• Strong technical analytical statistical personal organization and problem-solving skills
• Comfortable with laboratory automation systems and able to manage troubleshoot and enhance automated workflows
• Ability to work in a team environment and participate as an active member of management
• Effective oral and written business communication skills
• Ability to think strategically synthesize complex business and financial data and develop innovative solutions
• Must have a participative management style strong team development coaching skills and the ability to lead and motivate managers and team members
• Ability to establish priorities and follow through on projects paying close attention to detail with minimal supervision
• Proficient computer skills
• Ability to organize prioritize and execute a variable workload and multiple priorities

PHYSICAL & TRAVEL REQUIREMENTS

• Office and laboratory work environment
• Travel: 20-25%
• 5 hours per shift: Sitting standing handling finger dexterity pinching
• Up to 3 hours per shift: Walking climbing bending squatting reaching above shoulders reaching waist to shoulder reaching knee to waist reaching floor to knee grasping items carrying/moving items up to 40 pounds lifting to 40 pounds

The above statements are intended to describe the general nature and level of work performed by people assigned to this job. They are not intended to be an exhaustive list of responsibilities duties and skills required of personnel so classified. The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all the work requirements that may be inherent in the job. Creative Testing Solutions is an Equal Opportunity Employer.

Additional Job Details:

Shift 1

Monday to Friday Day Shift

Creative Testing Solutions is an equal opportunity employer.

EEO/Minorities/Females/Disabled/Veterans

Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability please send an e-mail to to let us know the nature of your request. A representative will respond to accommodation requests within two business days. Please note that this email/phone number is for medical/disability accommodations only and any other inquiries will not receive a response.

Please see the below information about applicant rights and our commitment to compliance:

EEO is the Law

EEO is the Law Supplement

Pay Transparency

e-Verify

All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Companys established guidelines.