Controlled Document Specialist I

at  Parexel

SUMMARY OF THIS POSITION:

Support the development, analyzes, documentation, and continuous improvement of controlled processes withing the company, as per current formats/standards which is a key component of the Quality Management System (QMS).

KNOWLEDGE AND EXPERIENCE:

• 1 - 3 years work experience (preferably in a related / administrative role)
• Experience in Clinical Research field (pharmaceutical industry or CRO) or other pertinent experience in the areas of QMS support preferred.
• Knowledge of Controlled Document management, process improvement or equivalent role in industry preferred.
• Knowledge of GxP compliance as required.
• Some experience in Quality Management preferred.
• Experience working in a global environment preferred.

EDUCATION:

• Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred or equivalent qualification or clinical research experience.

SKILLS REQUIRED FOR THIS POSITION:

• Excellent interpersonal, verbal, and written communication skills.
• Customer focused approach to work.
• A flexible attitude with respect to work assignments and new learning.
• Ability to manage and prioritize tasks efficiently and accurately.
• Willingness to work in a matrix environment and to value the importance of teamwork.
• Understanding analytics and basic statistics, logic design concepts.
• Understanding structured process analysis, improvement methodologies, business process modeling and an understanding of business workflows (Lean Six Sigma skills).
• Understanding of Quality Management System, Good Clinical Practice (GCP), FDA regulations, as well as current industry trends.
• Ability to lead projects and teams.
• Strong ability to analyze and interpret data.
• Good time management, multitasking and troubleshooting.
• Attention to detail and advanced organizational skills.
• Ability to work independently and take ownership of and responsibility for work assigned.
• IT literate – Experience with Microsoft based applications and a general knowledge of PC functions.
• Culturally aware and ability to think and work globally.
• Willing and able to travel as required – local or international.
• English proficiency (written and oral English).

KEY RESPONSIBILITIES OF THE POSITION:-

• Publish controlled processes in Parexel’s Electronic Document Management System which includes management of CD e-signature workflow.
• Educate and advise process owners on process improvement opportunities using methodology, data and fact and utilize recognized process improvement methodologies to eliminate waste/rework as well as break through improving business performance.
• Monitor/coordinate Controlled Document (CD) lifecycle and maintenance of the Controlled Documents Library.
• Support provisioning of external parties/clients to Parexel’s CDs, as appropriate.
• Oversee the Controlled Documents tools & trackers which supports the business as required.
• Oversee the allocation of Controlled Document numbering as required. Support the management of process deviations which includes consultation, publishing, management of deviation lifecycle and archival.
• Assist cross-functional teams with the integration of acquired companies into Parexel’s QMS, as required.
• Database, tools, and tracker maintenance.
• Administrative work (filing, copying, formatting, editing, proofreading).
• Managing Stakeholder-approved CDs through the BPM process, including Quality Control (QC), e-signature workflow, Master Binder administration.
• Lead improvement projects in own group to facilitate continuous growth and high-quality support to the rest of the organization, as required.
• Supporting maintenance of internal & external Pulse Pages.
• Work with business/functional units to determine analytical tools needed for process analysis and improvement projects.
• Drive projects in-order to improve process efficiency, as required.