Compliance Specialist, Quality Assurance - QA​/QC

Overview

The Compliance Specialist is responsible to support Manufacturing by investigating, authoring and managing non-conformance reports (NCRs) for production and environmental monitoring (EM) events. Assign corrective and preventative actions (CAPAs) and effectiveness checks (ECs) to address issues identified throughout production. Work with cross-functional teams, including production, quality control, quality assurance and facilities, to ensure efficient problem-solving and resolution of non-conformance issues. Communicate findings, actions, and improvements to relevant stakeholders and management.

• Non-Conformance Report (Client) Management:
  Investigate both significant and non-significant NCRs for production and EM events;
  Analyze data and identify the root causes to ensure a thorough investigation and identification of underlying issues;
  Write and maintain comprehensive Client reports, including all necessary details such as cause, impact, and actions taken.
• Corrective and Preventative Actions (CAPA):
  Work closely with cross-functional teams to develop and implement corrective and preventative actions in response to Client findings;
  Ensure CAPAs are well-defined, actionable, and address the root cause effectively;
  Monitor and track the progress of CAPAs, ensuring timely resolution and documentation of outcomes.
• Effectiveness Checks (EC):
  Conduct effectiveness checks (ECs) to assess the success of implemented CAPAs and Client resolutions;
  Analyze the results of effectiveness checks to ensure that corrective actions have been effective in preventing recurrence;
  Recommend further adjustments to CAPAs if necessary, based on the effectiveness checks.
• General:
  Attention to detail and thoroughness in investigation;
  Ability to work independently and manage multiple tasks simultaneously;
  Strong collaboration and interpersonal skills to work across teams;
  Ability to analyze data and identify trends or areas for improvement.
• HSE:
  It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility;
  The individual must support all Sanofi and site HSE policies as well as ensure that work performed is compliant with local HSE regulations;
  Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.

Education:

• High School Diploma or GED and 8-10 years' experience preferred
• Bachelor s Degree and 3-5 years' experience preferred
• Proficiency in using Microsoft Excel and Word

Qualification:

• 2+ years of experience in manufacturing, quality assurance, or related fields, with experience in managing NCRs, CAPAs and ECs.
• Knowledge of industry regulations such as GMP, ISO 9001, and FDA guidelines.
• Strong analytical, problem-solving, and investigative skills.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office Suite and document control software.