Primary Responsibilities
Ensures software applications are accurate, complete and conform to all user, company and regulatory requirements by
- Tracking all software versions, features, bugs and validation efforts for all software created and/or modified by the Development teams.
- Developing and utilizing test data sets that support the implementation of test plans and procedures.
- Creating and executing manual test scrips which includes testing software applications for quality and functionality using defined validation protocol and testing techniques.
- Creating associated validation documentation using defined documentation methods.
- Writing comprehensive test plans and reports which set strategy and summarize results.
- Working with application developers in resolving issues and retesting applications.
- Partnering with technical and business teams to achieve understanding of current and future functionality.
Ensures project leadership and test execution of staff by
- Working with professional and collaborative conduct
- Participate with both on site and off shore in daily operational activities for assigned projects
- Compiling and maintaining the documentation for an assigned project and working closely with Quality Assurance to obtain their sign-off and approval
- Communicating status frequently and noting current issues to the Manager.
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
- Exploring new opportunities to add value to organization and departmental processes
- Working with internal staff including technical staff, project and product managers and applications developers to assist with the review of project specifications
- Helping others to accomplish results
- Performing other duties as assigned and deemed necessary
Maintains Technical and Industry Knowledge by
- Attending and participating in applicable company-sponsored training
Education
Qualifications:
- Bachelors degree in Computer Science, Engineering, Life Sciences or related field required (Extensive experience and training may be considered in lieu of Bachelors degree.)
Experience
- 1+ years experience in validation/software testing required.
- Experience working with computer software including Word, Excel and SQL preferred
- 1+ years experience working with clinical trials and/or within pharmaceutical environment a Plus
- Knowledge of software development tools required, .NET, JAVA preferred.
- Proven ability in problem solving and troubleshooting.
- Proven mentoring and/or supervisory skills required.
Additional Skill Set
- Knowledge of Azure preferred.
- Knowledge of cloud based testing preferred.
- Ability to work in group setting and independently; ability to adjust to changing priorities
- Excellent attention to detail and orientation toward careful meticulous work
- Strong interpersonal and communication skills, both verbal and written
- Fluent in reading, writing and speaking English
- Strong documentation and organizational skills
- Ability to maintain professional and positive attitude
Working Conditions
Travel: 0-5%
Lifting: 0-25lbs
Other: Computer work for long periods of time
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