Compliance/Change Control Specialist

Hello This is Komal from Intellectt we have an opening for a Compliance/Change Control Specialist in Boston, MA. Please find the job details and description below and if interested You can reach me at komal@intellectt.com or call me at 1(732)-813-9025.

Role: Compliance/Change Control Specialist

Location: Boston, MA

Duration: Long Term on W2

Key Responsibilities

• Initiate the change control process. Gather information from the requesting department, bring information to the change control committee for endorsement, initiate the change control record in eQMS describing the change and the justification, drive the completion of the assessments, drive the agreement to the tasks, follow up on the completion of the tasks, submit the required documentation to close out the change control
• Work with technical SMEs (Regulatory, Engineering and Facilities, Manufacturing Science and Technology, Process Development, Supply Chain, Validation) to ensure the appropriate stakeholders are involved in the assessment of the change control and completion of the tasks
• Ensures the change controls are written to the best standards, with appropriate detail for review by regulatory agencies during audits
• Scope of change controls includes but not limited to: Introduction of new process equipment, changes to existing process equipment, technical transfer of new process from Process Development to Manufacturing, tech transfer between manufacturing sites, changes to existing process, scale-ups, changes to Raw Materials, introduction of new programs/strategies.
• Present change controls in the change control review board (CCRB) forum.
• Verify the impact of the change on regulatory filings.
• Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across CMC.
• Negotiate with QA partners: discuss requirements, ensure the documentation is completed appropriately for closure, etc.
• Establish and manage the timeline for completion of the tasks. Follow up with the task owners to ensure that the change control does not become overdue.
• Escalate any risks or issues encountered during the execution of the change control
  
  

Skills & Qualifications

• Approx. 5-8 years in a GMP environment in biotech/pharmaceuticals. Preferably as a manufacturing specialist, MSAT/PD, process engineering, or QA specialist
• Experience writing change controls for biotech (biologics preferred) in an electronic Quality Management System such as Veeva or Trackwise
• Experience with the tech transfer process. Understands the different purposes and cGMP requirements for pilot runs, engineering runs, PQ runs etc.
• Excellent written skills. Can write clearly and effectively without requiring major corrections or oversight. Ability to convey complex processes in straightforward language
• Ability to read and interpret complex technical documents, such as experimental protocols and reports, manufacturing batch records, and regulatory filings
• Strong sense of ownership. Role requires following up with stakeholders to ensure assessments and tasks have been completed.
• Problem solving and conflict resolution skills. Experience removing roadblocks and facilitating solutions.