Document and Training Management Specialist

PerkinElmer is a global technology leader driving growth and initiative in the Environmental and Human Health Science markets. The company is a leading force in the development, production, marketing, servicing, and support of laboratory instrumentation and ancillary services throughout the world.

Job Title:  Document and Training Management Specialist
Location: Lexington MA
Type of Assignment: Fulltime
 
Job Description: Primary Duties
             

• Under the direction of the line manager, the Pharmaceutical Development (PD) Documentation, Training and Compliance Specialist is responsible for supporting all the documentation, training and compliance needs.
• Provide and support documentation and training coordinator services to the PD organization including numbering, version control, formatting, processing, and filing of documents. Expert in using MasterControl or any Electronic Documentation Management System (EDMS).
• Support training profiles, maintain training records and submit document records within our electronic training tracking system. Expert in using SABA or any Electronic Learning Management System (ELMS).
• Support oversight and linkage to training curricula in compliance with GxP, regulatory requirements and Quality Manual/procedures.
• Documents and Training strategy materials are developed and maintained in accordance to Shire’s policies, procedures and standards.
• Provide support during internal and external audits related to regulatory, pre inspection approval and internal audits for PD organization.
• Support line manager in PD audit and inspection readiness plans.
• Assist with documentation, training, and compliance projects.

  Responsibilities % of Time Job Function and Description      
 
45%  
DOCUMENTATION:

• Support document issuance, version control, manual and electronic files maintenance, and document status notifications.
• Consult with functional heads regarding current document owners and business process owners.
• Follow-up on documents biennial review process.
• Perform logbook creation, review, scan, and file function.     
• Perform and support document formatting, printing and update document trackers.
• Expert in using MasterControl or any Electronic Documentation Management System (EDMS).
• Maintain the system current while doing quality checks from time to time.
• Maintain a complete and accurate index of documents.
• Issuance of reagents logbooks.
• Support internal and external audits and inspections.

       
 
45%  
TRAINING:

• Support and create training profiles, update training profiles on paper and electronic system, create training reports, maintain training metrics, etc.
• Consult with document owners and business process owners to determine training plan for procedural documents.
• Develop and maintain training contents for Instructor Led Training (ILT), On-the-job Training (OJT), Web-based Training (WBT) and knowledge Checks (KCs).
• Consults with hiring managers to identify appropriate curricula assignments for job roles.
• Expert in using SABA or any Electronic Learning Management System (ELMS).     
• Maintain the system current while doing quality checks from time to time.
• Perform and support administrative functions in our training tracking system: update training profiles, updates documents records, etc.     
• Assist with training and documentation projects.
• Support internal and external audits and inspections.

   
 
10%  
GENERAL:

• Assist, create and implement continuous business improvements projects.
• Creating weekly, monthly and yearly metrics.
• Assist in preparing newsletter and updating SharePoint site for the group.

    Education and Experience Requirements  

• Minimum Bachelor’s degree must.
• At least 2-3 years of Biopharmaceutical industry experience is preferable.
• Train-The-Trainer capability.
• Experience in designing training using various delivery methods.
• Exceptional training skills are required.
• Ability to interact well with and provide training to all levels of the organization.
• Documentation experience required (paper-based and as well as electronic system).
• Training system experience required (paper-based and as well as electronic system).
• Embrace Shire culture – operates with a high sense of urgency
• Embrace Shire core values -  BRAVE (bold, resilient, accountable, visionary and ethical)

  Key Skills, Abilities, and Competencies  

• Minimum 2-3 years of experience is required.
• Microsoft Suite detailed knowledge is must including SharePoint sites.
• Familiarity with style and formatting within MS word is must.
• Microsoft Excel pivot table’s knowledge is required.
• Expert in using MasterControl or any Electronic Documentation Management System (EDMS).
• Expert in using SABA or any Electronic Learning Management System (ELMS).
• Expert in using TrackWise or any Electronic Quality Management Software (EQMS).
• Must be able to learn complex software quickly and independently.
• Regulatory and compliance knowledge is must.
• Familiar with all the regulatory agencies and link them with CMC submissions processes.
• Must be able to work independently but also be customer service oriented.

  Complexity and Problem Solving  

• Emphasis on excellent customer service.
• Must be able to work independently and handle multiple projects at the same time.
• Must be able to work in a team environment and take directions from line manager.
• Prioritization decisions will be made by line manager.

• Able to solve problems and escalate issues to line manager.

      Other Job Requirements  

• Ability to participate in early and late meetings/teleconferences.
• Working hour’s flexibility to meet deadlines as needed.
• Ability to work overtime as needed.
• Availability during audits/inspections.      

   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Benefits at PerkinElmer

Competitive base salary and incentive compensation plan / Job training and professional development / Comprehensive benefits package / Paid time off and holidays / Tuition reimbursement plan / 401(k) with match