Oversees a corporate wide Laboratory Quality System inclusive of all staff, develops and maintains a written quality improvement plan and annual evaluation of the plan’s effectiveness.
Conducts quality audits of the Laboratory Quality System to verify that established quality policies and objectives are being met in accordance with accreditation criteria and Laboratory Quality System policies and procedures.
Monitors Laboratory practices to verify compliance with Quality System policies and procedures.
Coordinates and assists in the development of, and review training materials, testing procedures, and competency testing programs.
Monitor and schedule proficiency testing activities.
Assist with the establishment of criteria for new method and procedure validations.
Coordinate programs and procedures for Laboratory accreditation.
Participate in the identification and development of new quality metrics and provide periodic management reports.
Develops and reviews standards, policies, and procedures for all functions and departments involved with or related to the services provided by Kaycha Labs
Provides guidance over company quality metrics and promote programs to reduce deviations and failures.
Participates as an external assessor and/or inspector for regulator audits/inspections.
Responsible for attracting, developing and retaining best in class personnel. Must have the ability to create a high-quality work environment where the team feels engaged and accountable.
Maintains training records of Laboratory personnel.
Responsible for performing additional related duties as assigned.
Supervisory Responsibilities: Supervise the QA team within each lab
Knowledge, Skills & Abilities
B.S. or M.S. in clinical or forensic laboratory science, chemical, physical or biological science or in quality assurance/regulatory affairs, required
5+ years’ bioanalytical or regulated laboratory experience, required
Environmental lab experience a plus.
3+ years’ experience in a management and/or leadership capacity.
1+ years with external QA auditing experience.
ASQ or equivalent auditor certification a plus.
LEAN deployment and a continuous improvement mindset is a must.
Ability to read/audit complex technical data/procedures to determine compliance with existing polices, processes and procedures.
Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Ability to effectively present information and respond to questions from all levels of staff.
Ability to work effectively and diplomatically with inspectors and other regulatory personnel.
Must be able to identify/correct errors, define/resolve problems, collect data, establish facts and draw valid conclusions
Computer literacy; facility with standard MS Office tools (Word, Excel, E-mail, Internet, LIMS, etc.)
Excellent verbal and written communication skills, including technical language related to the laboratory environment
Exhibit professional and effective interpersonal skills
Up to 25% domestic travel may be required as deemed necessary to perform this job.
US Persons Only (US citizens, lawful permanent residents, refugee or asylee – all require proper identification and documentation)
Physical and Environmental Requirements: Typical work may require light lifting (less than 25 lbs.). Work environment includes lab operations.
Pre-Employment Verifications: Must pass Level 2 background check.
Kaycha Labs offers a competitive and comprehensive benefits package.
Kaycha Labs is an Equal Opportunity Employer - All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
Kaycha Labs is a leading provider of innovative Cannabis and Hemp testing technologies and methods. We perform product testing to help ensure compliance with state and federal regulations. We provide comprehensive cannabis testing for potency, homogeneity, heavy metals, microbial contamination, mycotoxins, residual solvents, terpenes, and pesticides.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.