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Electronic Document Management System Administrator

Blue Ash, Ohio
General Purpose of Position:
This position is primarily responsible for the module administration of Aprecia’s electronic document management system and collaborating with cross-functional departments to coordinate, create, and implement processes and procedures, ensuring that site quality compliance requirements are being followed at Aprecia Pharmaceuticals.

Primary Duties and Responsibilities (Essential Functions):
 
  Duties/Responsibilities
1 Responsible for administration of the electronic document management system (Master Control) ensuring seamless operation, maintenance, and user support
2 Develop and maintain installation and configuration management procedures.
3 Execute daily user administration tasks including creating, modifying, and disabling user accounts per approved procedures
4 Work closely with software provider to resolve system issues, propose enhancements, troubleshoot and resolve application issues, and test and implement additional functionality within the system
5 Proactively follow up on Master Control support issues to provide updates and resolutions to end users.
6 Coordinate and communicate with impacted stakeholders as needed.
7 Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle
8 Investigate deviations within the Master Control system and develop comprehensive correction action plans
9 Conduct final Quality review of GMP documentation within Master Control workflow
10 Perform essential day to day administrative hands-on tasks
11 Coordinate with process owners to deploy new modules, including developing and delivering training to process owners and users
12 Monitor and report on key quality metrics, identifying trends and areas for improvement; includes developing reports to enable efficient real time reporting
13 Support regulatory, organizational, and vendor audits as needed
14 Write and revise SOPs as necessary to ensure compliance, efficiency and clarity
15 Participate in quality and process improvement initiatives as well as project teams
16 Ability to work with minimal instructions on routine work and detailed instructions on new assignments
17 Other duties as assigned

Reporting to this Position:
No direct reports

Travel:
Position may require 0-5% travel

Work Shift:
This position works days

Knowledge, Skills and Abilities:
  • Understanding of GMP, FDA Regulations & Guidance’s (specifically 21 CFR Part 11) including industry requirements and trends toward preserving data integrity
  • Strong analytical and problem-solving skills with meticulous attention to detail
  • Excellent organizational and time management skills with the ability to manage multiple priorities
  • Demonstrated capability in solution deployment and project management skills
  • Proficiency in both written and verbal communication and presentations with the ability to work collaboratively in a team environment
  • Demonstrated ability to effectively interact with customers of all organizational levels
  • Proficiency in Microsoft Office Suite

Education and Experience:
  • B.S. degree in a scientific discipline or equivalent required or equivalent combination of education and experience
  • Professional with a minimum of 3 years of experience with systems administration in a pharma, biopharma/biotech or healthcare environment preferred
  • Familiarity and previous experience working with Master Control and/or other electronic document management system (Veeva, Documentum, Compliance Wire, etc.) preferably in a System/Document Administration capacity preferred

Physical Demands and Work Environment:    
  • Manual dexterity to operate keyboard, computer, and other general office equipment
  • Good eyesight to view a computer screen for extended period of time and read business/other communications
  • Good hearing to respond to training audience questions
  • Ability to sit at a desk for extended periods of time
  • Ability to walk or stand for extended periods of time
  • Ability to lift loads up to 25 pounds
  • Ability to perform filing duties, which requires periodic bending, squatting and/or kneeling
  • Ability to wear appropriate PPE (personal protective equipment as required for occasional exposure to pharmaceutical operations (i.e., respirators, over-gowning, gloves, steel toe shoes)

GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies.  The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position.  It is not intended to be an exhaustive list of all duties, responsibilities, and skills required.  The position may require other duties as assigned and can be changed at any time by the company.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.
 

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