We are looking for a Quality Specialist to oversee and perform activities necessary to provide confidence that specified Quality and Current Good Manufacturing Practices (cGMP) requirements applicable to materials, operational processes, and company products and services are fulfilled at Enviromedica. The successful candidate will be responsible for overseeing the operation of implemented Quality Systems, and other tasks to support the Quality department. The Quality Specialist must also adhere to all relevant regulatory standards and will report to the Quality Manager.
Enviromedica is a fast-growing natural products innovator, manufacturer and distributor located in North Austin, Texas. We have built out a beautiful facility which includes plenty of natural light, and contemporary design.
Job Duties and Responsibilities
- Maintenance of Document Control including maintenance of standard operating procedures (SOPs), quality control methods, master manufacturing records, and controlled forms.
- Review and disposition of manufacturing records. This includes, completing the batch release checklist for assurance that all required documents are reviewed and are found to be acceptable for release.
- Responsible for ensuring external laboratory testing is conducted on raw materials and products according to specifications.
- Perform review of Quality Control analytical documents including raw material analysis report, in-process bulk intermediates and finished products to ensure adherence to required internal specifications.
- Perform routine internal audits, identify and implement process improvements.
- Provide support for external and vendor audits.
- Assist with follow up on deviations (NCEs), CAPAs, and work with manufacturing to ensure they meet target implementation dates.
- Provide GMP training for new employees, new or revised documents, processes, or methods, and maintains the employee training records and database.
- Support activities for Quality
- Prepare and submit reports to the quality manager
Requirements
- Associate's Degree in biology, chemistry, or related scientific discipline or a minimum of two (2) years experience in an FDA regulated industry (i.e. nutraceutical / cosmetic / personal care or related bioscience industry)
- Bilingual a plus. (English and Spanish)
- Excellent written and verbal communications skills.
- Ability to easily learn and retain technical information.
- Attention to detail and ability to manage multiple priorities.
- Ability to understand production flow and evaluate related documentation.
- Adapts to changes in the work environment, manages competing demands and is able to deal with frequent change, delays or unexpected events.
- Actively promotes and personally observes safety and security procedures, and uses equipment and materials properly.
- Ability to work independently.
- Computer literacy and experience with MS Office (especially Excel and Word) and database systems.
Benefits
We offer an encompassing benefits package including Medical, Dental, Vision, 401k, PTO and 8 paid Holidays per year.
