What are the responsibilities and job description for the Validation specialist position at Spark life solutions inc?
Job Summary (W2 Only)
Job Title: Validation Specialist
Key Responsibilities:
- Develop and execute validation protocols, including IQ, OQ, PQ, and TMV.
- Maintain comprehensive validation documentation, such as Validation Master Plans (VMPs), reports, and SOPs.
- Conduct risk assessments and oversee change control processes.
- Ensure compliance with regulatory standards, including GMP, GLP, CSV, and data integrity requirements.
- Collaborate with cross-functional teams to support validation strategies and deliver training as needed.
- Monitor system performance and lead requalification efforts.
- Evaluate and qualify suppliers and vendors.
- Drive process optimization and support continuous improvement initiatives.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Minimum of 3 years’ experience in validation or quality within a regulated industry.
- Solid understanding of FDA regulations, ISO 13485, and 21 CFR Part 820.
- Proficient in Microsoft Office; familiarity with validation management software is a plus.
- Strong communication, documentation, and analytical skills.
- Preferred: Lean/Six Sigma certification; experience with Learning Management Systems (LMS).
Work Environment:
- Position involves work in both office and production floor environments.
- Requires effective verbal and written communication, computer usage, and occasional physical activity on the production floor.
Job Type: Contract
Pay: $30.00 - $38.00 per hour
Schedule:
- Monday to Friday
Work Location: In person
Salary : $30 - $38