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Sr. Operations & Compliance Specialist

Social Circle, Georgia


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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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Sr. Operations & Compliance Specialist

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Job ID R0033599 Date posted 04/20/2021 Location Social Circle, Georgia

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Job Description

Under general direction of associate engineering director, the operation & compliance specialist will drive, support, and improve compliance on engineering related activities assigned to the engineering department. Provide engineering support to the operations on day to day investigations, process improvement change control and CAPAS.

Manage and track to completion of change control, CAPAS, beacon, internal and external commitments. Track progress to ensure the plant goals are met on time completion of internal and external commitments. Assess continuous improvement opportunities. Demonstrate effectiveness in task completion, decision making, exception management, training, problem solving and team leadership. Trend, present and drive continues improvement from quality indicators in meetings.  

  • Supervise engineering compliance across multiple department and functions.
  • Manage medium and high-risk exceptions and ensure timely closure.
  • Lead in-plant audit ready status efforts for the engineering department.
  • Manage the initiation, tracing, investigation and completion of documentation and process related exceptions and corrective actions.
  • Lead problem solving and root-cause analysis sessions
  • Manage complex investigations using DMAIC tools
  • Ensure effective implementation of corrective and preventive actions
  • Responsible for organizing data and preparing appropriate documentation, including presentation materials, for assigned projects. Trend and present quality indicators for assigned areas in related meetings.
  • Write, review, and manage deviations, SOP, Job Plans and change control documents.
  • Prepare technical review and investigation. Organize data and prepare appropriate documentation for assigned projects.
  • Represent Engineering during Regulatory Inspections/Audit.
  • Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks.
  • Identify and implement improvement initiatives, reliability, and/or process robustness. This may require leading and implementing change controls.
  • Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability.

Bachelor's degree in Engineering discipline required. 5+ years of related experience. Some leadership experience preferred for supervisory roles.

This job posting excludes CO applicants.


USA - GA - Social Circle - Hwy 278

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Job ID R0033599
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