|
|
      
|
Pharmaceutical Clinical Associates, LLC
-
Bridgewater,
NJ
Ideal candidate will have demonstrated capabilities as an IT analyst supporting manufacturing, quality assurance, and quality control (laboratory analytics) in an FDA-regulated industry. The incumbent will learn the business processes of the areas supported, and identify opportunities for improvement with regard to both process and information, in the context of the overall information management strategy and architecture that they, with the rest of the analyst team, will develop and maintain. The incumbent will partner with their functional area clients to learn the longer-term business plan for the areas supported and be responsible for ensuring that all processes and systems delivered are in support of both the near- and the long-term vision. Candidate should possess experience in technology and architecture selection and development; requirements assessment and development at the macro, departmental, and cross-functional levels; governance model development; process mapping and optimization; phased implementation planning; training; implementation and ongoing support. Candidate will also have an awareness of, and relevant experience with, FDA regulations as they pertain to information systems, especially 21 CFR Part 11, and have experience supporting validated system implementation projects, and all requisite phases and tasks, within a service delivery model.
ESSENTIAL DUTIES AND
RESPONSIBILITIES
Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.
1. Interact with all levels of the Biopharmaceutical Operations group in the development, implementation, and ongoing support of their information management needs.
2. Support introduction of innovative IT solutions based on knowledge of the business while demonstrating core competency in information systems that support manufacturing operations, and a strategic approach to meeting business objectives.
3. Work with internal and external business and technical staff in the development of overall information management strategy, architecture and governance model for both the BioPharmaceutical Operations group and for the enterprise.
4. Work with internal and external business and technical staff to identify improvement opportunities, document requirements, identify solutions, etc., in support of the short-term needs and longer-term vision for the BioPharmaceutical Operations group.
5. Support technical projects from inception through delivery and post-production support within the framework of a structured service delivery model.
6. Participate on cross-functional teams, representing the information management and business process interests and vision of the BioPharmaceutical Operations group.
7. Author procedures, validation documentation, and other documents pertaining to the governance, administration, validation, and management of systems supporting the BioPharmaceutical Operations group.
Experience and Skills:
ESSENTIAL KNOWLEDGE,
SKILLS, EXPERIENCE
@
1. Bachelor of Science Degree in an information management, engineering, or manufacturing technology related field. Advanced degree preferred.
2. Five to 7 years experience in FDA-regulated industry, working on the specification, development, implementation, and administration of computerized systems in a cGxP environment.
3. At least 5 years experience in working with in a highly accountable role in the support of manufacturing and quality information processes and systems in an FDA-regulated industry.
4. Experience in managing technology delivery projects, from inception through delivery and post-production support, required.
5. Significant experience in the development and execution of computer validation documentation highly preferred, as is experience in the development and maintenance of procedures.
6. Experience developing training requirements and the training of users in a computerized system is a significant advantage.
7. Experience in establishing and supporting systems to collect, organize and visualize repetitive manufacturing process data from multiple source systems is a significant plus.
8. Must be self-motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
9. Ability to work on multiple, concurrent project initiatives.
10. Significant relevant experience with, FDA regulations as they pertain to information systems, especially 21 CFR Part 11, as well as relevant aspects of Sarbanes-Oxley
11. Excellent verbal and written communication skills are essential for this position. Excellent documentation and communication skills both verbal and written with ability to work independently.
12. Managerial or project leadership experience a significant plus.
Additional Information:
Job Level: Mid Career (2+ years)
Number of Openings: 1
Years of Experience: At least 5 Years
Level of Education: BA/BS
Salary: TBD
Starting Date : TBD
Email Job To A Friend
Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Bridgewater, NJ
Bridgewater, New Jersey
|
|
|
|
©2008 Pharmaceutical Clinical Associates
|
