Automation Analyst

Primary Responsibilities

Ensures software applications are accurate, complete and conform to all user, company and regulatory requirements by

• Planning, creating, and implementing automated verification processes
• Creating associated validation documentation using proper documentation methods
• Assisting in the development and maintenance of automated testing procedures, processes, and quality standards
• Performing troubleshooting methods as necessary to maintain a stable and effective automated testing environment
• Working with software developers to resolve issues and retest applications
• Evaluating and analyzing test results
• Participating in project team meetings as needed

Updating automated test scripts by

• Maintaining scripts and associated test matrices
• Identifying new areas for regression testing

Mentors junior validation staff by

• Assisting in the quality review of automated validation packages and providing related feedback
• Assisting staff with problem solving and troubleshooting issues

Maintains Quality Service and Departmental Standards by

• Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs)

• Assisting in establishing and enforcing departmental standards including defining, documenting and implementing validation standards as needed

Secondary Responsibilities

Contributes to team effort by

• Training staff on departmental processes, validation protocol, testing techniques and documentation methods.
• Performing code reviews and offer feedback on best coding practices when necessary.
• Evaluating, monitoring and prioritizing workload of staff to ensure projects are on time; affecting change when necessary
• Offering technical and quality feedback/advice to both internal and external client.
• Working with internal staff including technical staff, project managers and applications developers to assist with the development of project specifications
• Exploring new opportunities to add value to organization and departmental processes
• Helping others to achieve results
• Performing other duties as assigned

Maintains Technical and Industry Knowledge by

• Attending and participating in applicable company-sponsored training

Qualifications:

Education:

• Bachelor s Degree in Computer Science, Engineering, Life Sciences or related field required; Master s preferred.

Experience:

• 4+ years experience in validation/software testing required
• Experience working with test automation tools such as Coded UI, Selenium, Ranorex, Test Complete preferred
• Experience working with computer software including Word, Excel and Access preferred
• 2+ years experience working with clinical trials and/or within pharmaceutical environment preferred
• Working knowledge of the drug development process including knowledge of FDA requirements for GxPs and 21 CFR Part 11 preferred
• Proven problem-solving abilities

Additional skill set:

• Ability to adjust to changing priorities
• Strong understanding automated software QA methodologies
• Excellent attention to detail and orientation toward careful meticulous work
• Must be highly motivated, result-oriented, and possess the ability to handle multiple projects with multiple deadlines concurrently with minimal supervision
• Strong problem-solving, documentation and organizational skills
• Excellent oral and written communication skills
• Ability to project and maintain a professional and positive attitude

Working conditions:

Travel: 0-5%

Lifting: 0-25lbs

Other: Computer work for long periods of time

This position description should not be deemed all inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.

Acknowledgement

By electronically signing off on this document, I am acknowledging that I have received a copy of my job description and I understand my roles and responsibilities as it relates to my position.

EEO Statement

Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.