Quality Assurance Specialist II
2 weeks ago
As a Quality Assurance Specialist II, you will play a pivotal role in enhancing the quality standards within a life sciences manufacturing environment. Your expertise will be crucial in performing thorough investigations and implementing effective corrective and preventive actions (CAPAs) to ensure compliance and continuous improvement.
Key Responsibilities:
- Conduct in-depth investigations into process and product discrepancies, utilizing various root cause analysis techniques.
- Address customer feedback with professionalism and promptness.
- Manage troubleshooting for electrodes and buffer solutions.
- Implement and monitor CAPAs to mitigate future occurrences of deviations and nonconformities.
- Guide the assessment and disposition of non-conforming materials.
- Utilize statistical methods to evaluate process and product performance, responding proactively to any adverse trends.
- Lead change control initiatives for complex improvement projects, applying risk-based approaches.
- Exhibit expert knowledge of quality tools including FMEA, risk analysis, and Six Sigma methodologies.
- Participate in the development of risk assessments for both products and processes.
- Demonstrate a comprehensive understanding of validation principles, including protocol generation and statistical analysis.
- Ensure the site’s quality systems adhere to ISO standards and regulatory requirements.
- Drive continuous improvement initiatives across all operational areas.
- Support various audit processes, including internal, customer, and supplier audits.
- Perform Quality Assurance tasks to facilitate manufacturing processes and material release.
- Develop and update standard operating procedures and quality documentation as necessary.
- Prepare technical documentation, including investigation summaries and change management records.
Job Type: Full-time, Contract
Compensation: $35.00 per hour
Work Schedule:
- 8-hour shifts
- Day shift, Monday to Friday
Benefits:
- Health insurance
Work Environment:
On the road.
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