We are seeking a highly motivated Compliance Specialist to support our Manufacturing operations. This role is instrumental in maintaining product quality and regulatory compliance by investigating, authoring, and rigorously managing non-conformance reports (NCRs) related to production and environmental monitoring (EM) deviations. The successful candidate will be responsible for implementing robust corrective and preventative actions (CAPAs) and effectiveness checks (ECs) to mitigate risks and prevent recurrence of identified issues. This position requires strong collaborative skills to partner with cross-functional departments, including Production, Quality Control, Quality Assurance, and Facilities, ensuring prompt and effective resolution of all non-conformance events. The Compliance Specialist will also be tasked with providing clear, concise, and timely communication of investigation outcomes, remedial actions, and process enhancements to key stakeholders and leadership.
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.
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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