Streck is recruiting for a Quality Assurance Specialist to join our Quality Assurance area. This position will be responsible for quality activities performed in their assigned department(s), ensuring compliance with regulatory requirements and internal procedures. Under general supervision, this position provides day-to-day quality support to the designated departments.
The primary responsibilities include:
Assures that any observations/deviations are properly investigated and explained.
Provides guidance with Nonconforming process.
Provides support for the CAPA process to include CAPA investigation and closure.
Maintains awareness of activities by routine direct observation of processes. Interacts frequently with Operations staff to provide quality perspective on routine operations and support system. Addresses conditions/practices with appropriate personnel, documents and reports finding to Management.
Maintains Quality System reporting tools, such as error tracking spreadsheets and other documents as requested by management.
Performs batch/lot file reviews for compliance with appropriate SOPs
Bachelor’s degree in biology, chemistry or related discipline preferred. Demonstrated experience in an FDA or USDA production environment may substitute for technical education.
Minimum of one to four years of related work experience in an FDA regulated manufacturing environment.
Streck develops and manufactures products for clinical and research laboratories. Streck’s core technology is cell stabilization, and the pioneering research has led to the development of a number of patented products for use in hematology, immunology and molecular biology.
Streck is located in a state-of-the art facility just minutes from Interstate 80 in the southwest Omaha/LaVista area. We offer a collaborative environment with career advancement opportunities, competitive pay, comprehensive benefits, work/life balance and corporate wellness focus.
Streck, Inc. is an Affirmative Action / Equal Employment Opportunity employer - qualified applicants will be considered for employment without regard to protected veteran or disability status, race / color, religion, gender, national origin or any other legally protected basis.
Internal Number: 20-0015
Clinical laboratory products you can count on. Founded in 1971 and headquartered in Omaha, Nebraska, Streck manufactures hematology, chemistry, and immunology products for the clinical laboratory. Recognized worldwide as a leader in cell stabilization, Streck focuses on the development of products to help meet the fast-paced needs of clinical laboratories, with a continued commitment to innovation that addresses customer issues.Streck is a medical manufacturer that produces medical products and devices used in clinical laboratories throughout the world. This unique blend of industry provides an excellent working environment that is a combination of research, production, and administration. Streck is located in a state-of-the-art facility that provides a working atmosphere equipped with the latest technology.