What are the responsibilities and job description for the Investigation/Deviation Specialist position at S-Square Systems?
Roles and Responsibilities:
· Oversee the deviation process from initiation to closure, ensuring all discrepancies from standard operating procedures, specifications, or regulations are captured, investigated, and documented.
· Coordinate and lead detailed investigations of product deviations, identifying root causes and evaluating their impact on product quality, safety, and regulatory compliance.
· Work with teams across departments (e.g., Quality Assurance, Manufacturing, R&D, Regulatory Affairs) to gather data, conduct investigations, and identify process improvements.
· Guide investigation teams in performing detailed root cause analyses using methodologies like the 5 Whys, Fishbone Diagrams, and Failure Modes and Effects Analysis (FMEA).
· Analyze the potential impact of deviations on product quality, customer safety, regulatory compliance, and business operations. Assess whether deviations are isolated or affect multiple batches or products.
· Oversee the creation and implementation of CAPA plans to address root causes and prevent recurrence.
· Ensure CAPA plans are properly designed, implemented, and evaluated for sustained improvements. Verify the resolution of issues and effectiveness of actions.
· Maintain thorough documentation of product deviations, including investigation findings, root cause analyses, CAPA actions, and follow-up activities, in compliance with company and regulatory policies.
Strong knowledge of Good Manufacturing Practices (GMP), ISO standards, and relevant regulatory requirements (e.g., FDA 21 CFR Part 820 for medical devices).
Job Type: Full-time
Pay: $40.00 - $45.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Schedule:
- 8 hour shift
Education:
- Bachelor's (Required)
Experience:
- Manufacturing: 5 years (Required)
- Investigation/Deviation Specialist: 5 years (Required)
- GMP: 5 years (Required)
Work Location: On the road
Salary : $40 - $45
