Associate SOP Specialist

Job Description

POSITION OVERVIEW

The Associate Specialist, Document Control is responsible for the administration of the Document Management System at the Wilson Site.  This position also provides general and GMP-specific clerical responsibilities that vary in scope. 

The Associate Specialist, Document Control will report to the Associate Director, Quality COE.  

PRIMARY ACTIVITIES                                                                      

Document Archivist

• Responsible for Retrieval and tracking of Site Batch Records. This includes but not limited to retrieval from operations, archiving into the appropriate tracking system, scanning for Canadian Market, and finally filing in Document Retention room.

• Responsible for the tracking, retrieval, storage (including shipping offsite), retrieval challenge, and destruction of batch records beyond retention period as applicable managed in the Document retention room.

• Ensure proper allocation of Retention room capacity.

Controlled Print Activities

• Responsible for managing and executing controlled print requests for the site and laboratory.

• Responsible for the reconciliation of any High/Medium controlled print documents

• May require emergency requests during second, third shift, or weekends.

• Maintain/order printing supplies as needed.

Standard Operating Procedure management core responsibilities

Global Shared Services manages the site SOP Management program, but, in the event of an expedited request:

• Manage the Quality Docs DCC workflow process including but not limited to, creating the DCC, routing for review/approval, linking the draft.  

The site will be responsible for the following:

• Manage SOP 3-year review notifications for SOPs and Flowcharts

• Complete requests for previous versions of a Quality Docs SOP/WI/Job Aid/Template

Competencies/Leadership Behaviors/Skills:

• Excellent typing skills – formatting, spelling, etc.

• Ability to coordinate, log, track, and follow-up on outstanding items

• Self-motivated with a strong sense of urgency to meet timing requirements

• Work must be accurate and properly documented for GMP purposes

• Must be able to manage multiple tasks day to day

• Ability to achieve objectives requiring a high level of cooperation from others throughout the organization

• Must be able to prioritize tasks based on deadlines and schedule changes

Employees are expected to perform other duties or to accept other assignments to compensate for workload shifts as the need arises in addition to the major responsibilities listed above

SKILLS

Education Requirement:

• High School Diploma

Required Skills

• Functional experience in data or document management

• Excellent office software proficiency (MS Word, MS Excel, Visio, and Adobe Acrobat)

Preferred Skill

• Quality Management systems, cGMP, and regulatory inspections

• Excellent technical writing skills

• Detailed Oriented

• Learning and Development

• Project Management

• Problem Solving

#MSJR

VETJOBS

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