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Documentation Specialist II Jobs

Bridgewater, New Jersey
<p>Job Title:Documentation Specialist IIJob Location:Bridgewater, NJJob Duration: 6 monthsWork within the scope of Quality documentation Operations and Compliance Training Program to provide support for the operation and maintenance of the Quality Document Management process and training assignment within North America Quality (NAQ). Aids and assists in the daily management of various Quality Assurance operational functions. This position will also perform other special projects for NAQ, as needed.QDO:Work with the functional groups in North America business Operations to create/revise Quality Documents Representing North America (US & CA)Provide support in Quality document Migration activity.Reviews new and existing Quality Documents for compliance to Clients policies, directives and procedures as required.Support the operation and maintenance of the Quality Document OperationsEngage with stakeholders to migrate and manage the Quality documents across Business units.Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulator requirements.Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with othersTraining:Serves as the primary support for the management of training and tracking through the Learning Management System for North America.Maintains the Training Curriculum for North AmericaManage Learner profiles of US Q&C Learners within the [email protected] system.General ResponsibilitiesEnsure that the QDO and Training websites and various QA databases are maintained.Report regularly on activities to management when requested.Demonstrates required competencies on a consistent basis.Demonstrates company values on a consistent basis.Performs other duties as assigned.List required or preferred relevant qualifications, licenses, certificates, registrations, or any relevant knowledge, job skill or equivalent experience not covered in Educational/Experience sections above:The incumbent should possess significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical industry.Able to supervise and motivate Quality professionals in support of individual, departmental and corporate goals.Understands dynamics of the industry and stays current with developments and factors that can affect regional and corporate goals.Makes Customer and their respective needs a primary focus of individual actions, as well as develops and maintains productive customer relationships.Develops and uses collaborative relationships to work with managers to establish priorities and timelines to effectively self-manage workload.Is able to multi-task exceptionally well.Actively seeks information to find ways to resolve supporting or routine problems in a way that builds rapport and cooperation with everyone.Demonstrates the aptitude to learn about the functional areas and apply this knowledge to the work being done, adding value and insight over time.Accurately follows established procedures for completing work tasks.Advanced communication skills, both verbal and written.Self-motivated/directed.Ability to multitask in a highly stressful environment.Accurate/Efficient Typing Skills.Profiecient in Microsoft ofiice programs.</p>
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