Quality Assurance Officer I- Temporary Position
SSI Diagnostica Group
Summary
The Quality Assurance Officer I 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.
Job description
The Opportunity
The Quality Assurance Officer I 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
- Associates Degree + 1 year of experience in GMP/FDA environment
- B.A. or B.S.
- Life Science degree preferred but not required
- Must be able to lift upwards of 30lbs
Requirements
- High School Diploma +2 years of experience in GMP/FDA environment
- Associates Degree + 1 year of experience in GMP/FDA environment
- B.A. or B.S.
- Life Science degree preferred but not required
- Must be able to lift upwards of 30lbs
Company overview
SSI Diagnostica Group is a global leader in infectious disease clinical diagnostics, originally established as a division of the prestigious Danish National Reference Center – Statens Serum Institut. Founded in 1902 and currently owned by Adelis Equity, the company has grown significantly with headquarters in Hillerød, Denmark, employing over 600 people worldwide. The group specializes in innovative solutions for disease surveillance, diagnosis, outbreak investigation, and quality control across three key therapeutic areas: gastrointestinal, respiratory, and bloodborne diseases. SSI Diagnostica Group operates as a consolidated entity resulting from strategic acquisitions of five complementary companies – SSI Diagnostica, TECHLAB, Beijing Genesee Biotech, CTK Biotech, and Gulf Coast Scientific – bringing together more than 200 years of combined scientific expertise. The company develops, manufactures, and markets state-of-the-art IVD diagnostic kits and consumables including culture media, lateral flow tests, EIA & ELISA platforms that deliver fast and reliable results trusted by clinicians globally. With administrative and manufacturing facilities in Denmark, the United States, and China, and products distributed in over 130 countries, SSI Diagnostica Group serves approximately 60 million patients annually, empowering healthcare professionals to enable better treatment outcomes through accurate infectious disease diagnostics.