Compliance Specialist I

Ridgefield, New Jersey
September 9, 2025
$31 / hour
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Job Description

Job Summary:

  • 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.

Duties and Responsibilities:

1. 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.

2. 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.

3. 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.

Education and Experience:

  • High School Diploma or GED and 8-10years experience preferred.
  • Bachelors Degree in Engineering, Life Sciences, or related field (5-7 years experience preferred).
  • 2+ years of experience in manufacturing, quality assurance, or related fields, with experience in managing NCRs, CAPAs and ECs.

Knowledge, Skills and Abilities:

  • 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.
  • 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.

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