Director of Quality Assurance

About McKinney Specialty Labs

McKinney Specialty Labs is an innovative scientific organization that draws upon decades of extensive expertise in testing nicotine and other aerosolized products. We employ subject matter experts with extensive scientific knowledge, utilize robust and validated analytical methods, and offer testing flexibility to meet the diverse needs of our clients.

Our mission is to deliver best-in-class product testing and global regulatory science solutions to our clients through our experience, people and technology. We accomplish this by offering our clients the highest quality testing services in a state-of- the-art facility, all conducted according to our Values: Excellence, Collaboration, Integrity, Innovation, and Respect.

We are a new and growing company located in Richmond, Virginia. We offer competitive pay and a comprehensive benefit package, including medical, dental, vision and 401 (k).

To learn more, please visit our company website: https://mckinneysl.com/

Position Overview:

The QA Director is responsible for managing the entire Quality Management System, standards compliance, laboratory accreditations and lab safety program compliance. The QA Director is responsible for designing and implementing improvements in human, technical, safety and quality systems to improve data quality, operational effectiveness and efficiency. The QA Director functions independently from Laboratory Operations having responsibility for quality assurance and safety oversight independent of production and financial responsibility. The QA Director will report to the CEO.

Essential Duties and Responsibilities:

• Leading the laboratory’s QA and data quality improvement activities
• Manage the QA Team and QA personnel including the QA Analysts, the QA Internal Auditor, and Archivist
• Implementing and revising the QA program/QA Manual
• Ensuring SOP’s are written, organized and compliant to standards
• Completing, evaluating, reporting PE/PT results and corrective actions
• Organizing records and documenting personnel training, (IDOC’s)
• Providing QA program training for lab staff
• Documenting validation of new test & measurement services
• Proactively ensuring compliance to ethics program
• Performing and documenting Internal audits and data assessments
• Organizing, maintaining & completing standard reporting requirements (NELAC, etc.)
• Managing, maintaining, and expanding the lab’s accreditations and licenses
• Detecting, documenting, monitoring, resolving, and closing CARs

Necessary Qualifications:

To perform this job successfully, individuals must be able to perform each duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the duties and responsibilities.

• Bachelor's degree or equivalent and relevant formal academic / vocational qualifications.
• The QA Director must meet the minimum requirements of the accrediting body of the laboratory
• Working knowledge of industry regulations, ISO 17025/GLP/OECD or other regulated environments
• Working knowledge of analytical laboratory procedures
• Excellent written and oral communication skills
• Detail oriented with strong editorial and proofreading skills
• Previous experience leading direct reports, conducting performance evaluations, regular check ins, and career development for team members
• Time management skills
• Strong working knowledge of scientific terminology and/or research concepts
• Skilled in spreadsheets, table and graph generation and use of applicable computer software
• Ability to collaborate with lab team members to gather, interpret and consolidate data, generate documentation and reporting, review data and information for presentation and review
• Problem solving and troubleshooting abilities

Preferred Skills:

• Master's Degree or PhD preferred
• 3 years managing direct reports in a QA environment

The above statements are intended to describe the general nature of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties and skills required of employees so classified.

Application Process:

McKinney Specialty Labs is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. McKinney Specialty Labs does not discriminate in hiring or employment practices based on race, color, religion, gender, age, sexual orientation, marital or familial status, national origin, non-job-related disability, or status as a veteran.

If you are looking to make an impact in a dynamic and visionary company, we invite you to apply for this opportunity at McKinney Specialty Labs.

Job Type: Full-time

Pay: $91,185.00 - $98,445.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Commute:

• Richmond, VA 23228 (Required)

Ability to Relocate:

• Richmond, VA 23228: Relocate before starting work (Preferred)

Work Location: In person

Salary : $91,185 - $98,445