Quality Assurance Officer I
About The Position
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.
Requirements
- High School Diploma +2 years of experience in GMP/FDA environment
- Associate's degree + 1 year of experience in GMP/FDA environment
Nice To Haves
- B.A. or B.S. Life Science degree preferred but not required
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
