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.
Key Responsibilities:
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.
Key Competencies:
- 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.
Education:
- High School Diploma or GED and 8-10years experience preferred
- Bachelors Degree in Engineering, Life Sciences, or related field (5-7 years experience preferred)
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.
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