Job Description Summary

Job Description

PRIMARY DUTIES AND RESPONSIBILITIES

• Manages the Quality Assurance (QA) team for a specific laboratory location. Manages day-to-day quality production activities to ensure consistency and compliance across quality review, test result reporting, and donor deferral activities (plasma industry specific).
• Ensures appropriate staffing, development, training, and problem resolution across two or more shifts. Hires, supervises, trains, and evaluates the performance of assigned staff. Fosters a strong culture of empowerment, accountability, and inclusion, and seeks to develop team capabilities as well as foster personnel growth.
• Plans and analyzes workflow, delegates and prioritizes activities, and ensures assignments and projects are completed in a timely manner within budget. Ensures system output meets current requirements for laboratory quality standards and current regulatory guidelines.
• Manages and escalates quality and compliance issues to the attention of stakeholders based on risk to CTS and the clients served. Resolves complex problems and provides issue resolution.
• Manages laboratory tracking and trending data collection, analysis, and presentation for monthly Quality Management Review meetings. Facilitates proactive solutions based on quality data results.
• Leads the error management program. Supports operations by managing or performing evaluation of observations and errors. Works with involved departments to perform investigations, root cause analysis, and develop corrective action.
• Performs follow-up on audit observations. Tracks responses, monitors implementation and ensures the effectiveness of corrective action
• Leads and participates in process design activities for new and changed processes in identified operations.
• Participates in review teams to evaluate nonconforming products, materials, or test results and assesses the impact on customers. Ensures required actions are implemented.
• Advocates and leads annual and quarterly objectives as determined by laboratory leadership.
• Assists in the oversight of Clinical Trial Studies.
• Champions OE culture within areas of responsibility and actively encourages team member involvement.
• Implements and maintains appropriate leading and lagging indicators, which monitor process and product quality and effective execution of standard procedures.
• Partners with identified departmental leads on mitigating risks in processes, performance, or other factors that influence laboratory quality. Actively builds relationships to influence and collaborate cross-functionality.
• Facilitates and coordinates the CAPA program, which includes overseeing the successful implementation of and monitoring the efficacy of CAPAs.
• Ensures the analytic and result review processes meet regulatory standards and business needs.
• Acts as host and primary liaison for external and internal inspections/audits including, providing written responses as applicable. Ensures corrective actions were implemented and effective.
• Manages and facilitates recalls and market withdrawals.
• May perform review of documents as defined by CTS systems to ensure control of processes and adherence to cGMP requirements.
• 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.
• Performs all other duties, at the discretion of management, as assigned.

REQUIRED QUALIFICATIONS

• Education: Bachelor’s degree in science or quality related field required.
• Experience: Must possess at least five (5 ) years related experience in quality assurance in a Biological/Pharmaceutical environment required To include: previous supervisory or management experience, and previous project or technical leadership.
  • Depending on the area of assignment, directly related experience or a combination of directly related education and/or competencies may be considered in place of the stated requirements.
• Must possess demonstrated proficiency with Quality Assurance programs, systems and procedures including quality benchmarking, risk management, continuous improvement programs and industry specific regulations.

PREFERRED QUALIFICATIONS

• CMQOE, CQA, RAC, or Six Sigma certification preferred.

SKILLS AND ABILITIES

• Excellent leadership and people management skills, with a focus on building and developing high-performing teams.
• Ability to be organized and efficient, and possess a proactive attitude.
• Excellent communication and influencing skills, with the ability to collaborate effectively across all levels of the organization.
• Proven track record of successfully implementing quality initiatives and driving continuous improvement.
• Ability to demonstrate practical applications and flexibility in adapting programs and services to meet specific requirements.
• Able to organize, prioritize, and execute a variable workload and multiple priorities.
• Ability to work flexible hours to support a 24/7 work environment
• Ability to contribute to development and company objectives to achieve goals in creative and effective ways.
• Must have proficient computer skills.
• Ability to apply abstract principles to solve complex conceptual issues.

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: < 15%
• 5+ hours per shift: Sitting, Standing Handling. Finger dexterity, Pinching
• 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/moving/lifting items up to 35 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 1

Monday to Friday 8:30am to 5:30pm

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.