Validation Specialist
Pay: $25.00 and up depending on experience.
Hours: 7:00 am – 3:30 pm
Job Summary:
Responsible for developing, preparing, executing and overseeing the execution of and the revising of validation
procedures/protocols to ensure that there is sufficient documentation to support the manufacturing of a product in accordance with appropriate regulatory agency requirements, customer expectations, and internal company standards. Compiles and analyzes validation data, prepares reports and makes recommendations. Performs all tasks in accordance with cGMP guidelines and quality standards. Must be able to work in a team environment and possess team-based problem-solving skills. Must be results focused and oriented toward accomplishment of organizational goals. Must be able to work flexible hours to include overtime when needed.
Responsibilities:
- Ensure all processes and methods critical to product quality are appropriately qualified, validated and documented.
- Actively participate during all phases of validation including documents for IQ/OQ.
- Review engineering drawings.
- Analyze data and provide recommendations for improvements.
- Maintain system that tracks validation records.
- Write, review and approve validation strategies, protocols and reports.
- Review validation packages for completeness and accuracy, sound rationale, compliance with policies and procedures, and accurate data analysis.
- Establish priorities and schedule activities to ensure timelines and milestones are met.
- Some administrative activities may be required as needed.
Qualifications:
- Bachelor’s Degree in Science, Business
- Detail oriented
- Proficient in Math
- Basic communications and writing skills in English
- Ability to interact and work with team members
- Ability to communicate knowledge to team
- Must have knowledge of current industry expectations of validation requirements for
IQ/OQ/PQ/Cleaning/Equipment validations - Ability to handle multiple projects and deliver reports in a timely manner
- Ability to determine, present, and defend project requirements and status
- Must have knowledge of all current GMP requirements
- Ability to communicate written and verbally
