Vacancy expired!
- Completes more complex tasks with moderate direction.
- Completes routine tasks with no supervision.
- Work is self-directed.
- Executes non-routine decisions in their subject matter area.
- Participates in cross-functional teams, as subject matter expert for electronic documentation systems.
- Consulting supervisor for direction on managing personnel issues.
- Ability to fully interpret complex results and situations and articulate recommendations for resolution.
- Recognizes risk and develops contingency plans.
- Understands continuous improvement and improves efficiency and productivity within the group or project.
- Provides input within the function and cross-functional teams.
- Leverage's relationships internally within function and with cross-functional teams and supports cross-functional objectives.
- Manages conflict issues with internal customers and able to recognize conflict and notify management with proposed recommendation for resolution.
- Show basic negotiation skills within work group and team.
- Demonstrates coaching skills and assists manager in ensuring staff are properly trained on controlled, approved GMP and Document Control procedures.
- Relays shift communication to Document Control team.
- Escalates concerns/ issues to Document Control Management.
- Document Administrator for the global electronic GMP/GDP documentation system in compliance with regulatory and the Client's requirements.
- Contributes to effective documentation system KPIs, metrics, and proactive issue identification and resolution.
- Ensures that documentation complies with established electronic documentation system standards.
- Provides support during internal and health authority inspections of site facility.
- Executes documentation system-related Quality Systems Objectives as assigned.
- Serve as a Document Control Reviewer/Approver on documentation, managed through the electronic GMP/GDP documentation management system.
- Prints/Issues controlled documents, such as Master Batch Records and Batch Record Related documentation, logbooks, and analytical forms.
- Assists with maintenance and administration of procedures related to job function.
- Systematizes and streamlines document workflows.
- Provides end-user training on electronic document management systems.
- Supports Quality Systems harmonization efforts across the CTDO organization.
- Performs other tasks as assigned.
- Leads communication regarding potential issues to others in department. Coaches' employees to bridge knowledge gap.
- Possesses strong authorship; able to write and critically review reports.
- Provides guidance to others in technical writing and in interpretation of complex data.
- Fosters a team culture dedicated to enhancing customer satisfaction and building business partner relationships.
- Must be action Orientated with an independent mindset.
- Possesses conflict management techniques/ideas designed to reduce the negative effects of conflict and enhance the positive outcomes for all parties involved.
- Demonstrates ability to plan/organize and allocate resources.
- Must have GMP, Quality and risk management knowledge.
- Effectively prepares and conveys data analysis to management and others within group with clarity and accuracy.
- Possesses broadening technical knowledge and can analyze complete data in areas specific to job function at intermediate level.
- Contributes to the design and implementation of quality electronic documentation systems and practices.
- Demonstrates proficiency with PC-based office computers and standard Microsoft Office applications.
- Demonstrates ability to maintain current knowledge of applicable regulations and other regulatory changes.
- Relevant college or university degree preferred.
- Minimum 5 years of relevant industry experience, of which 2+ years of Document Control experience, is required.
- Experience with Veeva systems is preferred.
- Equivalent combination of education and experience acceptable.
- Previous experience in a gene or cell therapy facility is preferred (CAR T a plus).
- An equivalent combination of education and experience may substitute.
- The incumbent will be working 80% to 90% of the time in an office environment.
- The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
- The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
- Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time.
- Light to moderate lifting may be required, up to 25 lbs.
- Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. Extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.
- This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
- The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
- This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
- There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
- Employees holding this position will be required to perform any other job-related duties as requested by management based on business needs.
Vacancy expired!