Compliance Specialist I

Immediate need for a talented Compliance Specialist I. This is a 12 months contract opportunity with long-term potential and is located in Ridgefield, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID:25-61733

Pay Range: $35 - $38/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Non-Conformance Report (NCR) 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 NCR 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 NCR 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 NCR 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.

Key Requirements and Technology Experience:

• Key Skills:CAPA, NCR-non-conformance reports, Quality Assurance .
• 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 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.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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