Job Description

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 scripts 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.
• Accurately assessing the risks associated with each design solution / project.
• Exceling at business negotiation, ability to interact with clients, team members, various levels of management and external groups.

Ensures project leadership and test execution of staff by

• Leading by example with professional and collaborative conduct
• Determining necessary resources for project completion and communicating needs to Group Leader
• Leading testing resources 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 Group Leader

Mentors junior and off shore staff by

• Assisting in the quality review of validation packages and providing related feedback
• Training staff on departmental processes, validation protocol, testing techniques and documentation methods
• 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 clients

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
• Participating in the modification of company SOPs related to Validation Services

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

Qualifications:

Education:

• 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:

• 5+ years experience in validation/software testing required.
• Experience working with computer software including Word, Excel and SQL preferred
• 2+ years experience working with clinical trials and/or within pharmaceutical environment required
• Working knowledge of the drug development process including knowledge of FDA requirements for GxPs and 21 CFR Part 11 required
• 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. Collaboration, Continuous Learning, Critical Thinking, Organizational Awareness, Results Orientation, Service Orientation

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