Quality Specialist Lead

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;

OR

• 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;

OR

• 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 and SOP requirements, so as to conduct staff competency assessments and training.

PREFERRED QUALIFICATIONS

• Trainer Certification preferred.
• MT, ASCP (or equivalent) Specialty Certification preferred.

SKILLS AND ABILITIES

• Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.
• Must possess strong critical thinking and problem-solving skills.
• Must be able to maintain confidentiality.
• Must have proficient computer skills.
• Must be knowledgeable in computer operation in a Windows environment and able to follow company procedures to resolve issues.
• Ability to work in a team environment and participate as an active team member.
• Must be able to understand, follow, and give precise written and verbal instructions, and perform all activities safely.
• Must be able to read and comprehend written procedures and instructions.
• Professional with a wide range of experience and that uses company objectives to resolve complex issues in creative and effective ways.
• Must have the ability to prioritize demands, analyze, and evaluate information to make logical and compliant decisions.
• Must have leadership skills and promote teamwork.
• Must have skills to effectively communicate with a team and network with key contacts outside own area of expertise.

PHYSICAL & TRAVEL REQUIREMENTS

• Lab work environment: Exposure to biological fluids with potential exposure to infectious organisms. Exposure to extreme cold ( ≤ -20⁰C), miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on the production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Specific vision abilities required by this job include close vision, distance, color, peripheral vision, depth perception and the ability to adjust focus.
• Travel: < 5%
• 5+ hours per shift: Sitting, standing, handling, finger dexterity, pinching
• 3- 5 hours per shift: Lifting to 40 pounds
• Up to 3 hours per shift: Walking, climbing, bending, squatting, reaching above shoulders, reaching waist to shoulder, reaching knee to waist, reaching floor to knee, grasping items, carrying/move items up to 40 pounds

The above statements are intended to describe the general nature and level of work performed by people assigned to this job. They are not intended to be an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all the work requirements that may be inherent in the job. Creative Testing Solutions is an Equal Opportunity Employer.

Additional Job Details:

Shift 2

Wednesday to Saturday 11:00 AM to 9:30 PM

Creative Testing Solutions is an equal opportunity employer.

EEO/Minorities/Females/Disabled/Veterans

Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail to [email protected] to let us know the nature of your request. A representative will respond to accommodation requests within five business days.  Please note that this email is for medical/disability accommodations only and any other inquiries will not receive a response.

Please see the below information about applicant rights and our commitment to compliance:

Know Your Rights: Workplace Discrimination is Illegal

Pay Transparency Nondiscrimination Provision

E-Verify Participation

Right to Work

All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Company's established guidelines.