Software Validation Associate

MERIT is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We’re committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities

MERIT is seeking a full-time Software Validation Associate to have primary responsibilities include supporting the validation and verification of software used at MERIT through manual and automated testing and supporting the software development life cycle for MERIT proprietary software and Commercial Off-The-Shelf applications.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)

Software validation

• Support MERIT software validation activities for custom and Commercial Off-The-Shelf software
• Identify, investigate, and document software defects
• Verify proper functioning of new features and software defect fixes
• Develop and execute software test cases and test suites
• Aid in writing and maintenance of Software Requirement Specifications
• Assist with the development of software user guides/manuals/Standard Operating Procedures (SOPs)
• Understand the EXCELSIOR™ product, protocol and conduct of clinical trials in sufficient detail to be able to adequately discuss tasks with study team members

Other:

• Comply fully with company policies and SOPs
• Keep up to date with all assigned training
• Develop good documentation skills that meet the requirements of MERIT’s GxP (GMP, GCP, and GLP) systems 
• Other responsibilities may be assigned as required

The following are the essential functions of the position but are not all-inclusive.

• Practices and responds with commitment and sensitivity toward satisfying the needs of internal and external customers. Promotes quality and continuous improvement philosophy.
• Demonstrates a commitment to maintain safe, clean and orderly work area. Promotes and follows safety regulations and actively contributes to work safety.

QUALIFICATION REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience:

Minimum of a Bachelor’s degree in a health related, biological science, computer science related or business management (or minimum 1 year equivalent work experience). Experience with Software Development Life Cycle (SDLC), software validation or software testing preferred.

Other Skills and Abilities:

Excellent attention to detail, ability to follow direction, assess Company needs and work independently. Ability to work on multiple assignments and balance priorities to meet deadlines.

Excellent computer skills to include proficiency in Microsoft Office software and ability to learn Company specific software. Must be able to project a professional attitude and image appropriate for the work environment.

Ability to participate and contribute in a team environment as a team member. Oral and written communication is clear, concise, and effective. 

Licenses or Certifications Required: 

None.

Physical Requirements: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job

While performing the duties of this job, the employee is regularly required to use hands; to touch, finger and grasp, handle or feel, with repetitive motions, and talk or hear. The employee is frequently required to stand; walk and sit. The employee is occasionally required to reach with hands and arms, stoop, crouch, kneel and climb. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Benefits Offered: 

401(k)

Dental insurance

Disability insurance

Health insurance

Life insurance

Paid time off

Vision insurance

MERIT CRO, Inc. is an equal opportunity employer, and we are committed to hiring a diverse and talented workforce. 

It is the employment policy and practice of Merit to recruit and hire qualified employees without discrimination based on race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, national origin, ancestry, citizenship status, age, mental and physical disability, pregnancy, medical condition, genetic information, political affiliation, union membership, status as a parent, marital status, military or veteran status, or other classes protected by applicable law, and to not discriminate concerning compensation and opportunities for advancement, including upgrading, promotion, and transfers. We will provide reasonable accommodation to qualified individuals throughout the application, interviewing, and employment process. If you require reasonable accommodation, please contact us.