Job Description Summary
Under limited direction, this position is responsible for the supervision of the quality review and result reporting teams at CTS laboratories. Coordinates, monitors, and facilitates the collection, review, and release of test batch data according to applicable quality standards and production timeframes. Exercises independent judgment in methods and techniques used to resolve production-related issues. Serves as a resource to departments outside area of primary responsibility.
Job Description
PRIMARY DUTIES AND RESPONSIBILITIES

• Supervises and evaluates Quality Assurance (QA) team workflow and workload. Ensures the timely and accurate completion of day-to-day quality responsibilities.
• Integrates new or revised procedures into the routine workflow.
• Ensures all result review, release and reporting activities are performed according to standard operating procedures (SOPs). Provides quality assurance subject matter expertise.
• Supervises QA team training and ensures assigned staff possess the necessary competencies and abilities to meet workflow demands.
• Evaluates team performance by utilizing standard performance metrics. Provides updates on team effectiveness to management.
• Supervises archival record organization and classification activities. Ensures standard operating procedures (SOPs) are properly followed.
• Collaborates with Quality Management and Quality Analysts to facilitate and coordinate the tracking and trending of errors and incidents.
• Provides effective leadership on initiatives aimed to increase operational efficiency, lower costs, raise quality, improve Operational Excellence culture and/or standardize processes across multiple locations.
• Participates in and/or hosts internal and external regulatory and compliance audits. Reviews and evaluates audit findings to develop appropriate CAPA.
• Liaises with vendors and clients and provides direct customer service. Communicates with customers, vendors, and couriers to ensure quality service.
• Participates in the coordination of laboratory proficiency and blind sample challenges.
• Assists with the preparation of and/or review of testing equipment and software validation protocols as requested.
• Assist with the preparation of and/or review of validation protocols as requested.
• Ensures accurate records and documentation as required by established procedures and good documentation practice regulations. Ensures donor, patient, and employee confidentiality. Serves as a resource for corrections and clarifications.
• Partners with leaders in operationalizing the CTS strategic plan including goal setting and goal implementation
• Resolves complex problems and provides issue resolution. Analyzes and evaluates trending data to identify opportunities for improvement.
• Partners with personnel from various departments, leads departmental meetings, and escalates issues to Quality Management. Interacts with senior internal and external personnel.
• Participates in training and learning activities, and provides input on improvements, changes or projects.
• Assist in performing Quality Specialist activities as needed to keep the team on schedule.
• Supervises Quality Assurance (QA) activities and QA personnel. Hires, supervises, trains, and evaluates performance of assigned personnel. Identifies and effectively resolves personnel issues.
• 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: Bachelor's degree required.
• Experience: A minimum of 4 years of professional experience working in a cGMP regulated environment, To Include: at least 2 years of experience in a progressively responsible role, such as lead and/or supervisor and at least 1 year of workflow coordination experience.
• Must possess advanced quality competency expertise that meets regulatory and SOP requirements, so as to conduct staff competency assessments and training.
• Must possess demonstrated knowledge of Quality Assurance programs, systems and procedures including maintaining a Quality Management System and industry-specific regulations.

PREFERRED QUALIFICATIONS

• Bachelor's in biology, chemistry, or other science related degree preferred.
• Trainer Certification preferred.

SKILLS AND ABILITIES

• Ability to contribute to development and company objectives to achieve goals in creative and effective ways.
• Ability to work collaboratively with various departments to identify and implement solutions to address quality issues.
• Ability to listen to and understand information and ideas presented through written and oral formats.
• Ability to work independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
• Ability to interact with others, relay important information, and obtain consensus from diverse groups.
• Ability to apply abstract principles to solve complex conceptual issues
• Excellent and demonstrated leadership skills.
• Excellent oral and written communication skills.
• Ability to demonstrate practical applications and flexibility in adapting programs and services to meet specific requirements.
• Ability to establish priorities and follow through while executing a variable workload and multiple priorities, paying close attention to detail.

PHYSICAL & TRAVEL REQUIREMENTS

• Lab work environment: Exposure to biological fluids with potential exposure to infectious organisms. Exposure to extreme cold ( ≤ -20°C), 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
Monday to Thursday 12:30 PM to 11:00 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 accommodation@mycts.org to let us know the nature of your request. A representative will respond to accommodation requests within two business days. Please note that this email/phone number 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:
EEO is the Law
EEO is the Law Supplement
Pay Transparency
e-Verify
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.