Compliance Specialist

Job Title

Pay Range: $20hr - $25hr

Requirement/Must Have

• 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.

Responsibilities

• 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.
• 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 effectively address the root cause.
• Monitor and track the progress of CAPAs, ensuring timely resolution and documentation of outcomes.
• 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.
• Promote a safe working environment for employees and contractors working in their area of responsibility.
• Support all HSE policies and ensure that work performed complies with local HSE regulations.
• Complete all required HSE trainings.
• Report all accidents and incidents and support investigations in their areas of responsibility.
• Ensure timely closure of HSE actions owned by their departments.

Skills

• 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.
• Strong analytical, problem-solving, and investigative skills.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office Suite and document control software.

Education and Experience

• 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.