Quality Assurance Officer I- Temporary Position

About the Role

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.

Responsibilities

• Issuing and reviewing MBRs in support of Production schedule
• Issuing/confirming Lot Expiration Dates of Raw Materials, Components, and Finished Products
• Creating, reviewing, and applying QA Release Labels
• Reviewing QC results detailed per SOPs, RMSs, and PRSs
• Ensuring approved documents (MBRs, SOPs, TLFs) are issued and controlled
• Ensuring Controlled Records are controlled and easily retrievable
• Initiating proposed changes as Document Circulation Requests and Sage Change Requests
• Performing Visual Inspection of Raw Materials, Foil/Label Inspection, and AQL testing
• Ensuring Non-Conformities and CAPA are identified, investigated, and controlled
• Initiating Non-Conformity documentation and determining the Quality Impact
• Delivering New Hire Training
• Approving Lot Expiration Dates
• Dispositioning Pre-Raw/Raw Materials, Components, and Finished Goods
• Approving Manufacturing/Packaging MBRs
• Completing 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

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.