Quality Validations Specialist

Our Divisions :

Bulk Apothecary was founded in mid 2010 as a small brick & mortar specialty retailer in Streetsboro, Ohio and has since grown to become one of the nation's largest online suppliers of natural ingredients and essential oils. Our main focus from the beginning was soap and candle making supplies, but word of our fantastic prices, amazing quality and excellent customer service spread. Within 3 years, we expanded our offering to a wide range of specialty ingredients and vitamin supplements and had a dominant online presence that was growing by the day. Today, we still operate our small store in Streetsboro, Ohio but also have an online presence that's growth is nothing short of amazing.

Natural Essentials was founded in 1995 and has quickly grown to one of the Nation's premier contract filling companies. Because of our strong focus on quality, customer service and price, Natural Essentials has maintained outstanding growth in one of the worst economies in U.S. history. Today, Natural Essentials employees nearly 250 employees and manufactures products that are found in almost every retailer in the USA.

Quality Validation Specialist

Job Description :

The 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 8 : 00 a.m. until 4 : 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 review of equipment / systems.
• Critically review data to ensure completeness, accuracy and compliance.
• Apply CGMP and CGDP to all areas of work.

Required Knowledge, Skills, and Abilities :

Working conditions and Physical Effort :

Reports to Director of Quality Assurance.

Job Type : Full-time.

Pay : From $57,000.00 per year.

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!

Salary : $57,000