Quality Validation Specialist - Natural Essentials

• 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.

• Strong organization and communication skills; high level of personal/departmental accountability and responsibility.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
• Minimum of four (2) years of relevant GMP metrology, validation, or process engineering experience.
• Detail-oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Experience with Google Suite and Microsoft Office applications.
• Bachelors Degree in Engineering or a related degree

• Regularly able to lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.
• Standing, sitting, or walking for more than 8 hours a day.
• Able to work in high heat and humidity or cold and dry conditions indoors/outdoors.
• Full range of motion to lift, carry, walk, climb around equipment and facilities.
• Work in elevated positions on ladders, lifts, and platforms.
• Work involves moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors, and/or loud noises.
• This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
• Wearing PPE is necessary for the job.

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!