Quality Assurance Specialist
2 days ago
The responsibilities of the Quality Assurance (QA) Specialist requires exceptional attention to detail as well as specialized knowledge of laboratory practices and quality control procedures, especially as it relates to laboratory procedures performed at CND Life Sciences. The QA Specialist assists in creating and executing CND's quality assurance and quality improvement vision within the laboratory in addition to writing SOPs, policies and reports as appropriate. The Quality Assurance Specialist responds to reported quality issues in laboratory analytics and post-analytics, including risk analysis and corrective and preventative actions (CAPAs). The Quality Assurance Specialist communicates across pre and post-analytics to aid in the resolution of quality issues from the receipt of samples at the laboratory to the reading of the slide. The Quality Assurance Specialist maintains the laboratory equipment database and is responsible for using the LIMS system as it relates to quality control recordkeeping and filling and maintaining records and log books as appropriate. The Quality Assurance Specialist is expected to identify and communicate areas of improvement to leadership as needed and work to continuously improve and foster a culture of continuous improvement within the laboratory and beyond. The Quality Assurance Specialist shall aid in creating reports for quality metrics tracked across the laboratory and other laboratory duties as assigned. The position is required to adhere to HIPAA, CAP, OSHA, FDA, and other regulatory agency rules as they relate to the duties.
Job Responsibilities:
- Assists with collecting and collating pathologist QA data and reports
- Conducts quality metric reviews and corresponding reports related to laboratory quality.
- Performs laboratory quality control experiments and writes corresponding reports, including but not limited to water quality testing.
- Effectively assists with quality monitoring and evaluation of processes to include report design, graphical display, and analytical interpretation as needed
- Cooperates with the laboratory leadership team and other management teams to enable timely communication and review of reports
- Assists with maintaining laboratory regulatory requirements including assistance with CLIA/CAP and other inspections, or audits and inspection preparation
- Assists with reviewing and updating policies and procedures related to quality assurance, including continuous improvement of processes.
- Coordinates proficiency testing enrollment
- Ensures timely distribution of proficiency reports and monitors ongoing performance
- Assists with annual review of laboratory quality plans and measures to maximize performance improvement and error reduction processes
- Perform administrative and clerical duties as needed
- Provides data for and contributes to QA meetings
- Compiles data for and writes QA reports
- Knowledge of HIPAA rules and regulations
- Performs laboratory equipment maintenance and maintains equipment maintenance records
- Fills and manages maintenance quality control logs as appropriate
- Creates, administers and/or performs quality trainings included but not limited to good documentation practices, good lab practices, and procedure and policy review updates
- Participates in quality initiatives including recommending quality improvement actions
- Interprets procedures and clarifies questions on procedures and policies with lab staff.
- Performs internal auditing
- Maintains training and competency records
- Maintains complete and accurate technical files for laboratory personnel.
- Performs other duties as assigned
Knowledge, Skills & Experience:
- A minimum of (2) years full-time experience in a CAP or CLIA regulated environment or equivalent and experience with FDA regulations for medical device manufacturers
- Experience in laboratory quality control experiments, including but not limited to lot-to-lot testing and proficiency testing.
- Understands aseptic technique and safe handling of chemical, and other contamination in a research, development, and manufacturing setting.
- Understands appropriate application of quality control measures such as cross-contamination and equipment maintenance.
- Has knowledge of good documentation practices, such as in a medical device or other cGxP environment.
- Understands the application of quality control measures in laboratory work.
- Understanding and experience safe methods for handling biohazard materials and chemicals.
- Knowledge of clinical and infectious disease laboratory practice, including those with potential bloodborne pathogen exposure.
- Ability to establish working relationships with groups that have diverse backgrounds and significantly different needs
- Willingness and openness to professional development.
- Successfully managed a quality control improvement or routine quality performance report.
- Excellent written, verbal, and interpersonal communication skills are essential, and one must communicate technical concepts clearly to a diverse audience.
- Excellent attention to detail and ability to carefully audit processes and documentation of processes.
- Must be highly proficient in Excel and data analysis
- Strong computer-based skills, specifically with Microsoft Word and PowerPoint programs.
- Experience in training on laboratory and quality activities.
- Experience handling HIPAA and other sensitive or protected data types.
Education, Certifications & Licensures:
- Bachelor's degree in an applicable science required
Other:
- Ability to use copiers, fax machines, and PDF scanners to keep inventory and ordering records. Visual acuity and analytical skill to distinguish sufficient detail.
- Manual dexterity to use standard laboratory equipment and perform sterile techniques as required.
- Must possess the ability to sit or stand for long periods.
- Must possess the ability to perform repetitive motion.
- Ability to lift up to 25 pounds.
- May have exposure to biohazardous material in the lab environment. Exposure to xylene, paraformaldehyde, and alcohol, which emit fumes. Xylene is a known carcinogen and paraformaldehyde is a suspected carcinogen.
- Working with tissue that may contain blood-borne pathogens and use sharps. Hepatitis B vaccination is recommended and offered by the employer.
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