What are the responsibilities and job description for the Quality Assurance Officer I- Temporary Position position at SSI Diagnostica Group?
Join our team at the Techlab site, part of the SSI Diagnostica Group, as 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. This position will work through a staffing agency for the duration of the 5-month appointment.
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 Office 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
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.
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 Office 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
- 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
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.
Salary : $17 - $23