Position would require the candidate to be a W2 employee of Donatech
Under general direction, functions as the Chromatography Data System (CDS) Business Administrator, working at the Biochemistry QC HPLC laboratory. Implement CDS related improvements, including but not limited to development, validation, troubleshooting, documentation, change control and system administration in compliance with our client and regulatory standards.. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
FUNCTIONS
1. Responsible for the business administration of the Empower CDS, providing technical guidance and support to any related request.2. Provide reports, data analysis and ensure flow of communication between technical groups including following up and resolving issues that arise.3. Provide expert support to Laboratory Applications link to CDS. 4. Coordinates, manages, and performs changes to the CDS plan or in response to change requests approved by management.5. Work within the Information Services and Quality Systems teams to foster good communication throughout the project life cycle.6. Resolve technical issues and troubleshoot for assays as necessary.7. Ensure lab compliance which includes implementing procedures that enhance GMP, GLP and safety.8. Manage existing and/or develop and implement new programs, processes and methodologies9. Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.10. Support of laboratory investigations related to chromatography technology.11. May serve as subject matter expert to develop technical training.12. May perform routine work in a specific area of responsibility as necessary.13. Represents the department/organization on various team.14. Independently responsible for following through on multi-site action items.15. May interact with regulatory agencies regarding area(s) of responsibility including written responses.16. May resolve issues with outside resources.17. Performs special projects as requested by supervisor.18. Available to work overtime or weekends to conduct any special assignment as per business request.*Other functions that may be assigned
COMPETENCIES/SKILLS
1. Understand, support and demonstrate the client's values.2. Excellent communication skills, facilitation and presentation skills.3. Excellent technical writing skills.4. Strong computer operation skills including Word processing, presentation, database and spreadsheet application skills.5. Hands on experience using CDS, specifically Empower system.6. Strong knowledge as template builder in Empower, including development of custom fields calculations.7. Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.8. Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.9. Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.10. Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.11. Knowledge of pharmaceutical processes.12. Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.13. Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.14. Extensive knowledge and application of GMPs/CFRs.15. Ability to evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines.16. Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.17. Advanced scientific data analysis and interpretation skills.18. Advanced skills in solving complex problems.19. Advanced data trending and evaluation.20. Strong skill in working independently and to effectively interact with various level.21. Ability to interact with regulatory agencies both orally and in writing.22. Initiate, coordinate and lead cross functional team. 23. Excellent skill in leading, motivating, influencing, and negotiating.
PREFERRED QUALIFICATIONS
Major in Chemistry with approved Computer Sciences courses
Must have Strong knowledge as template builder in Empower, including development of custom fields calculations

About the Company:
Donatech Corporation