Quality Assurance Specialist

Provides key Quality support to the StimLabs organization

• Participates in Quality daily activities.
• Suggests and implements improvements within the Quality System and department.
• Acts as a quality representative within the organization, raising awareness for quality standards and education.
• Contributes to the development of quality-related infrastructure for new products
• Assists or lead on a variety of projects as designated by Quality Management.
• Member of StimLabs Internal Audit Team.
• Conducts all activities and documentation related to Quality Management System.

Participates in daily operations of the Quality department including but not limited to:

• Works with QMS team on the review, or creation of Deviations and Investigations,
• Collaborates with all groups to complete CAPAs and Complaints.
• Assist with Document and Change Control, Process Change Control, Facility Inspections, and Nonconforming Product processes.
• Works on Data Trends and Reports, as directed by Quality Management.
• Assists with records management and the Document Control system.
• General administrative tasks such as records review, filing, organizing, etc.
• Support inspections and audits from regulatory agencies, as needed.
• Support and perform Internal Audits when necessary.
• When applicable, assists as needed including but not limited to: Training program for all StimLabs employees. Training employees on new tasks/functions when designated by Quality Management. The development of Standard Operating Procedures, Work Instructions, Forms, sampling plans, and specifications.

EDUCATION/CERTIFICATION

• Bachelor’s degree in a technical field, with at least one to two (1-2) years of Quality Assurance and/or Quality Control experience in a pharmaceutical, medical device, biologic, or tissue banking FDA regulated facility; or an appropriate combination of education, certification and work experience.

REQUIRED KNOWLEDGE

• Knowledge and understanding of regulatory requirements, including 21 CFR 1271, AATB, cGTP, cGMP, and other applicable state and federal regulations. 
• Document Control Management (document changes as well as maintenance of Quality records) in a cGMP-regulated environment is required.  Experience in tissue banking is preferred but not required.