Documentation Specialist I

• Change Requests.
  

• Document control.
  

• Documentation System.
  

• Fully bilingual, fluent in English.
  

• Pharmaceutical Industries, biotechnology.
  

Overtime/Weekend work required due to business needs

Document control/change request experience is required

The primary responsibility is to create and process Change Requests for local and global documents. Also, to create the required Change Plans to process global documents.

• Process documents arriving in the area through the Documentation System.
  
• Add/review document properties.
  
• Approve documents and properties in the documentation system and release them for distribution.
  
• Circulate change management packages for review and approval, monitor approvers' responses, and ensure necessary approvals are obtained.
  
• Complete work according to established priorities, policies, practices, and procedures to ensure documentation is sent on schedule.
  
• Verify the impact of procedure changes on various operational systems such as SAP, LIMS, MES/POMS, Delta V.
  
• Verify synchronization of changes between operational systems and documentation.
  
• Coordinate changes among documents shared by the plants in Worcester, ABL, and Singapore.
  
• Train employees in system techniques.
  
• Receive, evaluate, and assign effective dates to documents.
  
• Communicate the status of procedures and Change Requests to initiators and negotiate implementation periods if necessary.
  
• Perform proofreading of documents received in the documentation area.
  
• Verify and receive documents; notify affected areas and the Training department of generated changes.
  
• Execute changes in SAP and DSP operational systems.
  
• Troubleshoot conflicts in the Documentation system or operational systems.
  
• Prepare/review manual PCRs (Process Change Requests) for use in the SVP (Small Volume Parenteral) and BDS (Bulk Drug Substance) areas.
  
• Manage the retention room and coordinate the transfer of documents to Iron Mountain.
  
• Provide operational assistance in accordance with Environmental, Health & Safety (EH&S) management systems and promote continuous improvement.
  

Minimum education, skills, and practical knowledge requirements:

• Degree in Sciences, Natural Sciences, with three (3) years of experience in pharmaceuticals/biotechnology.
  
• Candidates with a degree in secretarial sciences require 3+ years of experience in document control/change requests.
  
• High School diploma or GED + (5) years of experience in document control.
  

Minimum required experience (please include titles):

• Experience in document control area minimum of three (3) years.
  
• Continuous interaction with various plant departments, e.g., Validation, Training, Quality, Production, Engineering, IS, etc., at non-exempt staff levels up to plant management and with Documentation representatives in Worcester and Division.
  

• Document control/change request experience is required.
  

• Three (3) years of experience in Quality and/or Pharmaceutical Industries, biotechnology and/or Pharma, Biologics manufacturing, laboratory areas experience.
  

• Excellent organizational skills and team oriented.
  

• Fully bilingual, fluent in English.
  

• Excellent at managing computerized systems.
  

MBA

Office/Teams environment

1st shift

Candidate must be able and flexible to work overtime and weekends due to business needs.

1-3 Years