Job Description Summary
Under minimal direction, this position is responsible for the quality oversight of GMP IT systems in use at CTS. Reporting up through Quality, and in partnership with IT, this position is responsible for overseeing quality execution of the lifecycle, benchmarking and quality measures enhancement of software applications and other IT quality services in an evolving laboratory business. This position serves as a resource to the organization on technical quality concepts and models associated with development, configuration, use, and retirement of GMP software and other IT services.
Job Description
PRIMARY DUTIES AND RESPONSIBILITIES
* Collaborate with IT service management, project managers, software developers, application and system administrators, application support, and other stakeholders to identify and resolve quality issues and operational risks associated with software applications, IT projects and changes.
* Ensure changes to GMP software and IT services are performed according to CTS standards through QA review and approval of change records, active participation in the Change Advisory Board, and on project teams as needed.
* Ensure thorough testing of GMP software applications and IT services, including functional, regression, and performance testing such that systems are validated for their intended use and meet current GMP standards.
* Proactively assist IT in the development, implementation, and maintenance of procedures for IT systems and software applications so that they appropriately reduce quality and compliance risk.
* Review and approve standard operating procedures, protocols, and change records for the administration, validation and operation of computerized systems within a GMP environment.
* Assist with root cause analysis and CAPA implementation in errors that involve GMP software applications and IT services.
* Continuously improve QA methodologies and tools associated with SDLC oversight, based on lessons learned and evolving standards within industry best practices and the GMP environment.
* Create and/or execute end user test plans, test cases, and test scripts that meet GMP standards.
* Ensure software and IT services management and use follows industry standards, GMP regulations, and best practices.
* Have a thorough understanding of subject matter in area of responsibility and act as a resource.
* Maintain systems in areas of responsibility and ensure system output meets current requirements in a manner compliant with laboratory quality standards and current regulatory guidelines.
* Evolve as part of continuous improvement to cultivate change and innovation.
* Champion OE culture within areas of responsibility.
* Actively build relationships to influence and collaborate cross functionally.
* Perform all assigned duties in compliance with CTS policies and procedures. Bring compliance issues to the attention of management.
* Perform all other duties, at the discretion of management, as assigned.
REQUIRED QUALIFICATIONS
* Education: Bachelor's degree in computer science, life science or other related area required.
* Experience: A minimum of five (5) years of QA experience in software and IT services management within a GMP environment required.
* Subject matter expertise in the application of GMP regulations to software development and configuration (e.g., FDA 21 CFR Part 11, EMA Annex 11 and 22, data integrity, GAMP, computer systems validation).
* Demonstrated proficiency with QA programs, systems and procedures including quality benchmarking, risk management, continuous improvement programs and industry specific regulations.
* Demonstrated knowledge in software development life cycle (SDLC) methodologies.
* Familiarity with IT industry standards (e.g., ITIL, COBIT, ISO/IEC 12207, 90003 and/or
* Experience with using quality risk reduction tools (e.g., FTA, FMEA, VOC and CTQ, HACCP).
* Experience and proficiency in use of enterprise QMS software, IT service management software, and automated software testing tools.
PREFERRED QUALIFICATIONS
* Experience with automated testing frameworks.
* Familiarity with Agile and Scrum methodologies.
* Demonstrated life sciences industry knowledge in software Quality Assurance (e.g., ISTQB certification, SQA-CVIC active member).
SKILLS AND ABILITIES
* Attention to detail and a commitment to quality.
* Able to organize, prioritize, and execute a variable workload and multiple priorities.
* Ability to work in a matrix team environment and participate as an active member of management.
* Ability to work flexible hours to support a 24/7 work environment.
* Effective oral and written business communication skills.
* Ability to establish quality standards for novel work practices to ensure required outcomes.
* Excellent analytical and problem-solving skills.
* Strong communication and collaboration abilities.
PHYSICAL & TRAVEL REQUIREMENTS
* Travel: < 20%
* Office work environment
* 5+ hours per shift: Sitting, handling, finger dexterity, pinching
* Up to 3 hours per shift: Standing, walking, push/pull (20 lbs of force max), bending, squatting, reaching above shoulders, carry/move (40 lbs max), reaching waist to shoulder, reaching knee to waist, reaching floor to knee, grasp, lift (40 lbs max)
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:
This is a remote role, but must reside in one of the below states.
Arizona, Florida, Illinois, Missouri, North Carolina, Tennessee, or Texas
Shift 1
Monday to Friday 8:00 AM to 5:00 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 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.