Quality Assurance Software Specialist at MERIT CRO Inc

Madison, Wisconsin, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Dec, 25

Salary

0.0

Posted On

26 Sep, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Software Validation, GxP Compliance, Test Scripts, Risk Management, Interpersonal Skills, Project Management, Data Analysis, SaaS, Agile, Microsoft Office, Communication, Attention to Detail, Clinical Trials, Vendor Management, Documentation

Industry

Biotechnology Research

Description

Description MERIT CRO, Inc. 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 Primary functions include collaborating with the Quality Assurance and Compliance Department and subject matter experts (SMEs) in software validation to implement quality assurance review of validation deliverables and GxP activities within the company. Ensures the compliance of appropriate quality management tools, implements the related process. Assists in the development of validation deliverables such as software requirement specifications, test scripts, summary reports, and trace matrices in a GxP environment. Supports assessment and re-assessment of company vendors on a periodic basis. ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.) Review of software test cases and test runs for both customized and COTS software in support of the company’s validation activities. May include both automated and manual testing. Support and review activities include but are not limited to; review of validation deliverables such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) (IQ/OQ/PQ), traceability matrix, summary reports, and other report deliverables from validation projects Support and review project software development life cycle (SDLC) with company SOPs and risk management processes, in addition to review of risk management plans and risk management reports Ensure requirements (Software Requirement Specifications, SRS) are adequately tested following a risk-based approach established by the company and industry standards such as GAMP5 and the FDA’s Computerized System Validation Guidelines Understand the EXCELSIOR™ product and conduct of clinical trials in sufficient detail to be able to adequately discuss tasks with cross functional teams Comply fully with MERIT policies and Standard Operating Procedures (SOPs) Ensuring that company validation deliverables are developed, reviewed and maintained in accordance with company processes and procedures Vendor and external contractor qualifications and audits assist in conducting vendor and contractor qualifications vendor and contractor maintenance activities. Assists in the development, review and administration of user manuals, policies, training and SOPs Provide training for implementation of internal and regulatory requirements Ensure that SOPs are being followed during daily operations: CAPA, deviations, non-conformances, document control, change control, software development life cycle, validations, training, and documentation Assist in implementing regulatory guidelines into MERIT QMS Generate regular and ad-hoc reports as needed to support project progress Provide progress updates to internal stakeholders pertaining to projects’ status Develop and maintain awareness of industry standards and best practices 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. Requirements 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: Preferred BA or BS degree from a four-year college or university with related experience and/or training in a clinical research, quality assurance or service-related environment. Equivalent experience may be substituted for education at the discretion of the manager. Preferred a minimum of 1 years’ experience in quality assurance in the medical device, pharmaceutical or GxP industry or 1 years’ experience in quality assurance in the technology industry. Other Skills and Abilities: Strong interpersonal and organizational skills, excellent attention to detail, ability to follow direction, assess Company needs and work independently. 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. Excellent planning and project management skills. Preferred basic knowledge computer system design, architecture, implementation, integration, and IT infrastructure. Preferred basic knowledge of underlying infrastructure requirements supporting GxP systems and common related IT technologies, e.g., SaaS, AWS, Azure, etc. Preferred basic experience with data analysis tools such as Excel, SQL, R, or similar tools and data visualization tools such as Zoho Analytics, SAS, Tableau, or other tools. Preferred experience with IT project management methodologies, such as Agile, and supporting technologies such as Jira. 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 CRO, Inc. 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.

Responsibilities

The Quality Assurance Software Specialist collaborates with the Quality Assurance and Compliance Department to implement quality assurance reviews of validation deliverables and GxP activities. They support the development of validation deliverables and ensure compliance with company processes and procedures.