Qa Associate I

Description:

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 health, dental and 401k.

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

POSITION OVERVIEW

McKinney Specialty Labs is hiring for a QA Associate I. The QA Associate I ensures data quality by reviewing laboratory data, workflow, and procedures with the goal of assuring data of known quality and accuracy.

A QA Associate I will:

• know the requirements of the laboratory’s accrediting body,
• be competent operating within the laboratory’s Quality Management System (QMS), and
• have read the methods for the assays they review and be familiar with the laboratory procedures for those methods.

This position reports to the QA Director or Group Leader.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Review of customer data to ensure its compliance with McKinney Specialty Labs' quality system, the reference methods, and the customers' requirements.

• Review of customer data to ensure its compliance with McKinney Specialty Labs' quality system, the reference methods, and the customers' requirements.
• Writes and edits basic to moderately complex analytical reports for potential submission to regulatory authorities and clients.
• Collect and interpret data whose intent is to track laboratory quality control data trends or to document the lab's performance (control charts, audit sample data).
• Perform internal audit activities as directed by the QA Manager.
• Review and update SOPs per the review schedule as directed by QA Manager.
• Archive data according to SOPs.

Requirements:

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 preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience.

PREFERRED SKILLS

• Good working knowledge of scientific terminology and/or research concepts
• Good knowledge of word processing, 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
• Working knowledge of industry regulations, ISO 17025/GLP/OECD or other regulated environments
• Working knowledge of analytical laboratory procedures
• Effective written and oral communication skills
• Detail oriented
• Time management skills
• Good editorial and proofreading skills
• Good problem solving and troubleshooting abilities
• Ability to work well in a collaborative team environment
• Must be flexible in work schedule and able to work overtime (including weekends)

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.