Compliance Specialist II

2 weeks ago

Cambridge, United States Randstad Life Sciences US Full time

Job Description

This exciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing compliance improvement through deviation resolution, applied root cause analysis, and the application of CAPA to elevate safety, quality, cost, on-time delivery, and right-first-time performance. The Compliance Specialist supports by working cross-functionally with internal support departments to drive improvements to completion.


Job Responsibilities

  • Lead event investigations to adequately identify root causes and implement appropriate corrective and preventative actions to prevent reoccurrence,
  • Lead CAPA investigations and at times manage the implementation of CAPA.
  • Own manufacturing-related change controls.
  • Responsible for organizing data and preparing appropriate documentation, including presenting materials, for assigned projects.
  • Recommending batch record and SOP improvements to reduce or eliminate GDP errors or correct root causes of deviations.
  • Review production documentation and perform quality walk-throughs during manufacturing events
  • Participate in continuous improvement teams such as 5s, Gemba, and Production Systems (GPS).
  • Provide training and guidance to team members on compliance-related matters to promote a culture of compliance throughout the organization.
  • Lead team meetings and facilitate multidepartment discussions.
  • Stay current with biopharmaceutical industry best practices and technologies.
  • Other duties as assigned


Education & Qualifications

  • Bachelor's degree or equivalent experience.
  • 3+ years of related experience.
  • Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single-use technology (SUT).
  • Experienced with standard troubleshooting approaches (problem statement, root cause analysis, Ishikawa (fishbone diagram), 5 Whys).
  • Good computer skills, and knowledge of Microsoft Office products – Word, Excel, Office.
  • Collaborate with cross-functional teams to integrate compliance measures into various aspects of manufacturing operations.
  • Ability to work in a clean room environment and comply with hygiene standards and use of cleanroom gowning.


Preferred Qualifications:

  • If you have the following characteristics, it would be a plus:
  • SME or experienced with some or all of the following process equipment; homogenizers, tangential flow filtration (TFF), ultrafiltration/diafiltration (UFDF), Single-use technology (SUT), buffer preparation, and filtration.
  • Experience with regulatory agency interactions and inspection discussions preferred but not required.
  • Excellent verbal/written communication skills.
  • Facilitation and demonstration skills
  • Attention to detail and the ability to work individually and within multi-disciplinary teams
  • More advanced knowledge/proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP, SAP)

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