Compliance Specialist

Location: Ridgefield, NJ
Duration: 24 months

About the Role

The Compliance Specialist supports Manufacturing by investigating, authoring, and managing non-conformance reports (NCRs) for production and environmental monitoring (EM) events. They assign corrective and preventative actions (CAPAs) and effectiveness checks (ECs) to address identified issues, working with cross-functional teams to ensure efficient problem-solving and resolution. The role involves communicating findings, actions, and improvements to stakeholders and management.

Responsibilities

• Non-Conformance Report (NCR) Management:
  • Investigate both significant and non-significant NCRs for production and EM events.
  • Analyze data and identify root causes to ensure thorough investigation and resolution.
  • Write and maintain comprehensive NCR reports, including cause, impact, and actions taken.
• Corrective and Preventative Actions (CAPA):
  • Develop and implement CAPAs in collaboration with cross-functional teams.
  • Ensure CAPAs are well-defined, actionable, and address root causes effectively.
  • Monitor and track CAPA progress, ensuring timely resolution and documentation.
• Effectiveness Checks (EC):
  • Conduct effectiveness checks to assess the success of implemented CAPAs and NCR resolutions.
  • Analyze EC results to ensure corrective actions prevent recurrence.
  • Recommend adjustments to CAPAs based on effectiveness checks if necessary.
• Health, Safety, and Environment (HSE):
  • Promote a safe working environment and comply with client and site HSE policies.
  • Complete all required HSE trainings and report accidents, incidents, or hazards.
  • Support investigations and ensure timely closure of HSE actions.

Key Competencies

• Attention to detail and thoroughness in investigation.
• Ability to work independently and manage multiple tasks.
• Strong collaboration and interpersonal skills for cross-team work.
• Analytical skills to identify trends and areas for improvement.

Requirements

• Education/Experience:
  • High School Diploma or GED with 8-10 years of experience, or
  • Bachelor’s Degree with 3-5 years of experience.
• Qualifications:
  • 2+ years of experience in manufacturing, quality assurance, or related fields, with NCR, CAPA, and EC management.
  • Knowledge of industry regulations (e.g., GMP, ISO 9001, FDA guidelines).
  • Strong analytical, problem-solving, and investigative skills.
  • Excellent written and verbal communication.
  • Proficiency in Microsoft Office Suite and document control software.