What are the responsibilities and job description for the Quality Validation Specialist position at Natural Essentials?
Quality Validation Specialist
Job Description :
The Quality Validation Specialist is responsible for performing complex validation and qualification activities for critical equipment, utilities, and processes used in cGMP. This position will need to travel frequently between the Manufacturing Facility and the Distribution Facility. The hours for this position are 7 : 00 a.m. until 3 : 30 p.m., overtime may be required, and the hours may need to be adjusted during peak periods, or to meet the needs of the company in certain situations. This is a Salaried Exempt role, due to the nature of the position.
Duties and Responsibilities :
- Write and execute validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc.
- Writes detailed validation reports and analyzes complex quality data.
- Plan and execute cleaning validation activities
- Perform and / or coordinate cleaning studies, spray coverage testing, cleaning verification swabbing, and rinse sampling.
- Provide technical input for control strategies for the introduction of new products, as it relates to Cleaning Validation.
- Maintenance of the Cleaning Validation equipment and product matrix.
- Analyze statistical data to verify acceptable criteria.
- Maintains revalidation schedules ensuring the facility remains in a validated state.
- Writes and reviews SOP’s related to qualification activities.
- Provide technical support / troubleshooting for process and equipment issues.
- Attend production and team meetings, as required.
- Troubleshoots and rectifies issues that are complex in nature.
- Maintain close contact with manufacturing and laboratory departments to assure effective communication on issues related to validation.
- Apply CGMP guidelines to all aspects of validation.
- Investigate / resolve deviations associated with validation studies.
- Author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
- Provide technical and / or investigational support in troubleshooting and resolving manufacturing equipment issues.
- Perform periodic reviews of equipment / systems.
- Critically review data to ensure completeness, accuracy, and compliance.
- Apply CGMP and CGDP to all areas of work.
- This position will need to travel frequently between the Manufacturing Facility and Main Office Building.
Required Knowledge, Skills, and Abilities :
Working conditions and Physical Effort :
Reports to Director of Scientific and Regulatory Affairs.
About Natural Essentials :
Natural Essentials, Inc. DBA Bulk Apothecary is a growing company that specializes in providing high-quality raw materials, essential oils, and other basic cosmetics to customers around the world. We are committed to providing our customers with the best possible products and services, and we are looking for talented and experienced associates to join our team!
