Business Analyst in Durham, NC at Apex Life Sciences

Date Posted: 11/9/2018

Job Snapshot

Job Description


Our client is hiring a Business Systems Analyst at their RTP location. If qualified, please email your resume to Sarah at sdiscepoli@apexsystems.com

We are a leading CDMO (Contract Development and Manufacturing Organization) in the pharmaceutical industry employing some 3,500 employees with headquarters in Sweden. We operate a development facility located in Research Triangle Park, North Carolina, USA.

Our RTP location comprises analytical services and preformulation as well as development of a range of dosage forms. The company has an outstanding reputation and expertise in the specialized fields of respiratory, topical and parenteral product development. The company is currently expanding with the implementation of a new GMP suite requiring continuous development of sponsor specific processes.

We are seeking a Business Analyst to join us in our Information Technology (IT) group. In this role you will be responsible for assisting staff at the site with computer system validation activities, including leading small projects and authoring all required documents for validating computer systems and system-generated reports. This is an important initiative for the site in which the candidate will be working with staff from IT, Quality Assurance (QA), and end users of the various systems.

In this position, your key responsibilities will be to:     

  • Document functional requirements and technical specifications for existing and new applications for computer system validation (CSV) activities
  • Lead CSV activities, including project planning, documentation requirements and milestone dates
  • Work together with IT, end users and QA to ensure the correct requirements are documented and understood
  • Develop an understanding of end-user business processes and translate them into user requirements
  • Work with customers/end-users to advise on strategies, alternatives and the implications of specific application customizations and interface designs
  • Create test scripts and queries to facilitate requirements gathering and test method execution
  • Perform test case effectiveness on user-reported defects and provide feedback to improve the testing process
  • Provide support and assistance during User Acceptance Testing (UAT) for end users
  • Proactively resolve issues and questions as well as communicate project status to stakeholders
  • Develop Microsoft Excel worksheets with built-in automation via VBA code, including leading validation of user-created spreadsheets

Required Qualifications:

  • Solid understanding and experience with 21 CFR Part 11 requirements for electronic records/electronic signatures
  • Ability to quickly understand multiple and varied computer softwares to assist with controls and reporting functions
  • Ability to work independently and with various levels of technical and non-technical personnel
  • Ability to operate effectively either independently or in teams
  • Demonstrate a degree of creativity with strong analytical and problem solving skills
  • Excellent organizational, planning, and time management skills
  • Must be flexible and be able to function in a fast paced and dynamic environment

Preferred Qualifications

  • Experience with the pharmaceutical industry is a plus
  • Understanding and application of working in a regulated environment

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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