Deviation Investigation Engineer Job Frederick area,Maryland USA,Quality Assurance

Position: Deviation Investigation Engineer-(Urgent Hiring)

Job Description

Key Responsibilities:

Deviation Documentation:

Document deviations from standard operating procedures (SOPs), batch records, and other manufacturing processes.
Ensure all deviation reports are accurate, complete, and compliant with regulatory standards (e.g., FDA, EMA, ISO).
Draft detailed deviation reports that include the nature of the deviation, potential impact, and initial assessment.

Investigation:

Collaborate with cross-functional teams (e.g., Manufacturing, Quality Control, Engineering) to investigate the root cause of deviations.
Gather and analyze data, interview personnel, and review documents to determine the cause of deviations.
Identify potential corrective and preventive actions (CAPAs) to prevent recurrence of deviations.

Corrective and Preventive Actions (CAPA):

Document and track CAPAs related to deviations.
Follow up with relevant departments to ensure CAPAs are implemented effectively and in a timely manner.
Monitor the effectiveness of CAPAs and recommend further actions if necessary.

Regulatory Compliance:

Ensure that all deviation documentation and investigations comply with regulatory requirements (e.g., FDA 21 CFR Part 211, EU GMP).
Assist in preparing documentation for regulatory inspections and audits.
Stay up-to-date with industry regulations and best practices related to deviation management.

Reporting and Communication:

Communicate the status of deviation investigations and CAPA implementation to management and relevant stakeholders.
Prepare summary reports on trends and recurring issues related to deviations.
Participate in regular meetings to review ongoing deviations and CAPA status.

Continuous Improvement:

Participate in continuous improvement initiatives to enhance the deviation management process.
Recommend changes to SOPs, batch records, and other documents to prevent future deviations.
Provide training to employees on deviation reporting and investigation processes.

Qualifications:

Education: Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Quality Assurance).
Experience: 1+ years of experience in quality assurance, quality control, or a related role in a regulated industry.
Knowledge:
- Familiarity with regulatory requirements (e.g., FDA, EMA, ISO standards).
- Understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Knowledge of root cause analysis tools and techniques.
Skills:
- Strong technical writing and documentation skills.
- Excellent attention to detail and analytical abilities.
- Effective communication and collaboration skills.
- Proficiency in using quality management systems (QMS) and deviation tracking software.

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