Job Description Summary

Under the direction of the manager, this position works independently and serves as a technical subject matter expert for assigned applications including Laboratory Information Systems(s) for all Creative Testing Laboratories (CTS). This position is responsible for configuring, maintaining, troubleshooting, and/or updating the applications portfolio as well as maintaining any interfaces in the environment. Develops automated and non- automated testing scripts for application validations. Performs administration tasks for the assigned applications. As a senior member of the Applications team, this position helps guide application support, business process improvements, major application changes, knowledge sharing, and planning for future needs.

Job Description

PRIMARY DUTIES AND RESPONSIBILITIES

• Maintains required software configurations to meet evolving business and user needs.
• Leads and implements solutions that add value, are stable, and can be supported through the product lifecycle.
• Collaborates with both internal and external healthcare partners, the CTS Applications Manager, and enterprise architects to ensure business needs are understood and addressed.
• Serves as the senior resource for assigned applications, helping guide application support, business process improvements, and decisions about future enhancements and changes.
• Partners with vendors, business stakeholders, and IT teams to evaluate application changes and technical solutions, helping ensure they meet business needs and can be effectively supported by CTS.
• Leads and supports major application initiatives, including new implementations, upgrades, integrations, and other significant changes to business-critical systems.
• Partners with laboratory and business stakeholders to identify opportunities to improve processes, simplify support, standardize configurations where appropriate, and strengthen application support across CTS.
• Creates and maintains documentation that meets CTS software development lifecycle (SDLC), change control, quality, and validation requirements.
• Represents IT in assigned project discussions and helps keep application work moving by communicating clearly, raising concerns, and following decisions and action items through completion.
• Provides subject matter expertise for the applications supported by CTS IT, including internally developed and vendor provided applications.
• Troubleshoots complex production applications, interfaces, laboratory instruments, hardware, and software issues. Provides issue coordination through resolution.
• Develops, executes, and reviews test plans, including automated test cases when appropriate.
• Keeps application documentation and support procedures current. Cross-trains other team members to share critical knowledge and ensure continuity of support.
• Provides day-to-day technical guidance and mentoring to application analysts, administrators, and other team members without direct supervisory responsibility.
• Participates in disaster recovery planning, application recovery testing, contingency planning, and business continuity exercises for assigned applications.
• Builds shared knowledge and support capability across lab applications as CTS aligns laboratory application environments.
• Performs all duties in compliance with internal SOPs and applicable FDA, cGMP, and quality requirements. Brings compliance concerns to management.
• Provides quality service to CTS customers.
• Maintains good attendance and punctuality in accordance with the absence policy.
• Performs other duties as assigned by management.

 

REQUIRED QUALIFICATIONS

• Education: Bachelor's in a relevant field or equivalent combination of education and experience.
• Experience: A minimum of 8 years of related enterprise application experience, or an equivalent combination of education and progressively responsible experience.
• At least 2 years of experience with programming languages and SQL commands.
• Experience independently supporting, administering, improving, or implementing business-critical applications.
• Experience with server platforms and operating systems.
• Experience with computer system validation methods and procedures.
• Experience leading technical work, solving complex application problems, or coordinating work across business and IT teams.
• Experience documenting processes, sharing knowledge, mentoring others, and building backup support for critical responsibilities.

 

PREFERRED QUALIFICATIONS

• Experience supporting or administering Laboratory Information Systems.
• Experience supporting laboratory operations or another FDA-regulated environment.
• Experience with Automated validation tools.
• Experience providing support to a laboratory focus work environment.
• Knowledge of computer change processes and applicable FDA and cGMP requirements.
• Knowledge of standard disaster recovery and business continuity processes.
• Experience with application implementations, upgrades, integrations, migrations, or major system changes.
• Experience reviewing technical solutions or recommendations from vendors and implementation partners.
• Experience supporting multiple laboratory locations, business areas, or application groups.

SKILLS AND ABILITIES

• Works independently with minimal supervision and knows when to involve other team members or leaders.
• Willing and able to learn new technologies and understand the business processes they support.
• Provides technical leadership and influences decisions without direct supervisory authority.
• Understands laboratory business processes and can translate business needs into practical, supportable application solutions.
• Balances immediate operational needs with long-term support, compliance, cost, and business needs.
• Identifies what needs attention, takes ownership, and follows work and issues through completion.
• Shares knowledge, mentors others, and helps build backup coverage for critical responsibilities.
• Maintains confidentiality.
• Uses strong analytical and problem-solving skills.
• Organizes and prioritizes a changing workload with multiple priorities.
• Communicates clearly and works effectively with customers, team members, business partners, vendors, and all levels of management.
• Works effectively as part of a team.  
  

PHYSICAL & TRAVEL REQUIREMENTS

• Office work environment
• Travel 20-25%
• 5+ hours per shift:  Sitting, reaching waist to shoulder, finger dexterity
• Up to 3 hours per shift:   Standing, walking, bending, squatting, kneeling, handling, driving, reaching above shoulders, reaching waist to shoulder, reaching knee to waist, reaching floor to knee, grasping items, lift/carry/move items up to 40 pounds, push/pull items up to 10 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:

Day Shift

This is a remote position, but reside in one of the below states and be in commutable distance to our labs for on-site visits. Charlotte, North Carolina, Tempe, Arizona, Bedford, Texas, Memphis, Tennessee, San Marcos, Texas, Maryland Heights, Missouri, and St. Petersburg, Florida.

This role will require the person hired to be on call during off hours at least a week per month.

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.