Quality Specialist Lead NY

mycts; Charlotte (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

mycts is seeking a Quality Specialist I-III to oversee review and approval of routine testing, ensuring cGMP compliance and accurate final results for laboratory customers.

You will coordinate team schedules, train staff, participate in audits, investigate CAPA deviations, and provide guidance on quality data trending and documentation. A Bachelor’s degree in Medical Technology or related sciences with CLIA/high-complexity experience is preferred.

Qualifications

• Bachelor's Degree in Medical Technology with at least 4 years of lab experience, including workflow coordination.
• Bachelor's or higher in chemical, physical or biological sciences with CFR 493.1489 training and 4 years lab experience.
• Master's Degree in chemical, physical or biological sciences with CFR 493.1489 training and 2+ years lab experience.

Responsibilities

• Review and approve routine testing of biological samples.
• Coordinate team schedules and communicate production information.
• Support vendor and client communications to ensure quality service.
• Investigate issues with testing and CAPA deviations.
• Conduct competency assessments and document training.
• Assist with audits and ensure SOP compliance.
• Maintain records and confidentiality.

Skills

Quality control

Documentation

Training

CAPA

Audits

Data trending

Regulatory compliance

GxP

Education

Bachelor's Degree in Medical Technology

Bachelor's or higher in chemical/physical/biological sciences

Master's Degree in chemical/physical/biological sciences

Job description

Job Description Summary

Under minimal supervision and using independent judgment, this position is responsible for applying standard procedures to ensure test results, including the quality of cGMP laboratory testing processes, are met for final approval and release to laboratory customers. Coordinates and provides guidance to quality specialist teams. Ensures required outcomes by providing quality methodology expertise.

Job Description

PRIMARY DUTIES AND RESPONSIBILITIES

• Oversees and performs review and approval quality control and verifications for the routine testing of biological samples. Ensures thorough test batch review and verifies that all source data meets quality attributes and cGMP regulation conformance prior to result reporting. Approves final test results for release to laboratory customers.
• Coordinates team schedules. Communicates daily production information to ensure smooth shift-to-shift production transitions.
• Liaises with vendors and clients and provides direct customer service. Communicates with customers, vendors, and couriers to ensure quality service.
• Investigates issues of varying complexity with testing, quality control, and preventative maintenance. Ensures immediate corrective action and escalates to appropriate management. Assists with laboratory proficiency and blind sample challenges.
• Conducts required competency assessments and completes documentation. Recommends appropriate corrective action as necessary.
• Provides routine and non-routine training to staff and ensures all training and/or re-training is documented.
• Assists with workflow coordination. Integrates new or revised procedures into routine workflows.
• Participates in internal and external audits.
• Assists with investigating, documenting, and completing CAPA associated deviations.
• Serves as a primary resource for guidance, clarification, complex problem-solving and issue resolution.
• Completes constructive investigations and resolves batch review discrepancies.
• Ensures accurate records and documentation as required by established procedures and good documentation practice regulations. Ensures donor, patient, and employee confidentiality.
• Maintains archival record organization and classification. Ensures standard operating procedures (SOPs) are properly followed.
• Collects, analyzes, and documents trending data for key performance indicators.
• Provides advanced cross-departmental and/or cross-site support. Liaises with personnel of all levels from various departments and sites.
• Maintains assay process expertise performed at the laboratory.
• Performs all other Quality Specialist I - III duties, as necessary.
• Participates in performance improvement teams and training programs, as required.
• Assures quality customer service to all customers.
• Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
• Maintains good attendance and punctuality per the absence policy.
• Performs all other duties, at the discretion of management, as assigned.

REQUIRED QUALIFICATIONS

• Education & Experience Option 1: Bachelor's Degree in Medical Technology, At least 4 years of subsequent laboratory experience, to include at least 1 year of workflow coordination experience;
• Education & Experience Option 2: Bachelor's Degree or higher from an accredited institution in chemical, physical or biological sciences where education and training meet CFR 493.1489, Six months of supervised relevant training/experience and at least 4 years of subsequent laboratory experience, to include at least 1 year of workflow coordination experience;
• Education & Experience Option 3: Masters Degree from an accredited institution in chemical, physical or biological sciences where education and training meet CFR 493.1489, Six months of supervised relevant training/experience and at least 2 years of subsequent laboratory experience, to include at least 1 year of workflow coordination experience.
• CLIA requirements for High Complexity Testing required.
• Appropriate state licensure and/or certificate, where applicable, required.
• Must possess High Complexity Testing competencies required by Standard Operating Procedures (SOPs), CLIA, and other applicable regulatory and accrediting bodies required.
• Must possess demonstrated advanced clinical laboratory knowledge and competency so as to provide testing quality control, as well as proficient training and guidance to newer staff.
• Must possess demonstrated proficiency of complex equipment and reagent maintenance, for troubleshooting, and problem resolution. Advanced proficiency must be demonstrated with all equipment at the assigned location.
• Must possess demonstrated understanding of, and experience with, proficiency survey sample testing.
• Must possess demonstrated equipment calibration and qualification proficiency for all equipment at the assigned location.
• Must possess advanced clinical laboratory competency expertise that meets regulatory an