Provide front-line support for assigned company GXP computer systems with a focus on MasterControl and other Quality related computer systems.
- Manage user accounts, create/manage workflows and other configuration setting, modify/create new application reports, etc. Experience with MasterControl highly desired.
- Work with users, and management as well as software vendors to identify, troubleshoot and resolve problems.
- Prepare change control documentation related to troubleshooting and preventive maintenance activities according to company SOPs.
- Assist with computer-related aspects of new system installations.
- Participate in company-wide quality computer system validation (CSV) projects by providing assistance in drafting, reviewing and executing validation plans, URS and FRS documents and IQ/OQ/PQ protocols and test scripts.
- Provides updates, status, and completion information to manager, problem request tracking system, and/or users, via voice mail, e-mail, or in-person communication.
- Review existing computerized systems for compliance to company procedures, computer validation requirements, data integrity and 21 CFR Part 11 compliance as assigned.
- Performs other duties as assigned.
- Bachelor’s degree in Computer Science or related field with 4 years hands on experience in Computer system administration or equivalent combination of education and experience.
- Extensive knowledge of cGMPs, 21 CFR Part 11, regulatory requirements and ICH guidelines. General awareness of computer validation methodologies and/or software development life cycles prefer experience with GAMP 5.
- Knowledge of computer network and system security principles. Working knowledge with any of the following system/areas; document management, quality systems, lab systems, LIMS.Ability to work independently and drive projects. Excellent written and oral communication skill, good decision making skills and time management skills.
- Strong expertise and ability to interview and accurately interpret communication requirements of team members. Proficient in the use of Microsoft Office and other applications as applicable, plus the ability to learn company used applications as required.
Knowledge and Skills
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee is frequently required to walk and sit. The employee is occasionally required to stand and stoop, kneel, crouch, or crawl.
Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.