Quality Assurance Officer I
We usually respond within two weeks
Join our team at the Techlab site, part of the SSI Diagnostica Group, as a Quality Assurance Officer I and help shape the future of healthcare technology. This is an opportunity to contribute to meaningful innovations in a collaborative environment focused on improving patient outcomes.
About Us
We are a global company specializing in the design, development, and manufacture of IVD medical device kits. Our mission is to improve patient outcomes and transform healthcare delivery through technology and a commitment to quality. Our portfolio includes solutions for infectious disease, respiratory conditions, and blood-borne illnesses. We foster a culture of collaboration, continuous learning, and professional growth.
The Opportunity
The Quality Assurance Officer 1 is responsible for ensuring that all TechLab® Inc. products meet the requirements of the quality system. This can include reviewing and tracking product as well as reviewing documentation to ensure it complies with regulatory standards. The Quality Assurance Officer 1 reports to the Quality Assurance Manager or the QA Supervisor.
Key Responsibilities
Issuing and reviewing MBRs in support of Production schedule
Issuing/confirming Lot Expiration Dates of Raw Materials, Components and Finished Products
Create, review and apply QA Release Labels
Review QC results detailed per SOPs, RMSs and PRSs
Ensure approved documents (MBRs, SOPs, TLFs) are issued and controlled
Ensure Controlled Records are controlled and easily retrievable
Initiating proposed changes as Document Circulation Requests and Sage Change Requests
Perform Visual Inspection of Raw Materials, Foil/Label Inspection and AQL testing
Ensure Non-Conformities and CAPA are identified, investigated and controlled
Initiate Non-Conformity documentation and determine the Quality Impact.
Deliver New Hire Training
Approve Lot Expiration Dates
Disposition Pre-Raw/Raw Materials, Components, and Finished Goods
Approve Manufacturing/Packaging MBRs
Complete projects as assigned by QA Manager or QA Supervisor
Qualifications and Experience
High School Diploma +2 years of experience in GMP/FDA environment
Associate's degree + 1 year of experience in GMP/FDA environment
B.A. or B.S. Life Science degree preferred but not required
Location and Work Policy
TechLab® maintains a climate-controlled environment for the job of Quality Assurance Officer 1. An employee in this position must be able to lift upwards of 30lbs. A typical workday is Monday through Friday 8:00 to 4:30 or 8:30 to 5:00. Overtime is occasionally necessary with or without advance notice.
We are an equal opportunity employer and value diversity. We do not discriminate based on sex, race, color, religion, national origin, gender identity or expression, sexual orientation, age, disability, pregnancy, status as a veteran or any other class protected by law.
TechLab, Inc. participates in the federal E‑Verify program to confirm the employment eligibility of all newly hired employees. Learn more about your rights and responsibilities under E‑Verify at www.e‑verify.gov.
- Division
- Quality & Regulatory (QA, QC, RA, CE)
- Department
- Quality Assurance (QA)
- Locations
- Radford
- Yearly salary
- $44,000
- Employment type
- Full-time
Radford
A unique career - Join us
About SSI Diagnostica Group
SSI Diagnostica Group, a global leader in infectious disease clinical diagnostics, was originally established as a division of the prestigious Danish National Reference Center – Statens Serum Institut. Currently held by Adelis Equity, the SSI Diagnostica Group has grown significantly and now has its headquarters in Hillerød, Denmark. The company employs over 600 people across the globe and offers innovative solutions for disease surveillance, diagnosis, outbreak investigation, and quality control in three key areas: gastric, respiratory, and bloodborne diseases.
With administrative and manufacturing facilities located in Denmark, the United States, and China, and a strong global network of distribution partners, the SSI Diagnostica Group continues to build its position as a leading supplier of reagents and in vitro diagnostic (IVD) products worldwide.
Already working at SSI Diagnostica Group?
Let’s recruit together and find your next colleague.