Quality Assurance Officer I

About the role

The Quality Assurance Officer 1 at TechLab, Inc., part of the SSI Diagnostica Group, plays a crucial role in ensuring that all products meet quality system requirements. This position is part of a global company specializing in IVD medical devices, committed to improving patient outcomes and transforming healthcare delivery.

Responsibilities

• Issuing and reviewing Material Balance Reports (MBRs) in support of production schedules

• Issuing/confirming Lot Expiration Dates of raw materials, components, and finished products

• Create, review, and apply Quality Assurance Release Labels

• Review QC results according to Standard Operating Procedures (SOPs), Risk Management Plans (RMSs), and Process Review Sheets (PRSs)

• Ensure approved documents (MBRs, SOPs, TLFs) are issued and controlled

• Control and easily retrievable Controlled Records

• Initiate proposed changes as Document Circulation Requests and Sage Change Requests

• Perform visual inspection of raw materials, foil/label inspection, and AQL testing

• Identify, investigate, and control non-conformities and Corrective Action Preventive Action (CAPA)

• Deliver new hire training

• Approve Lot Expiration Dates

• Disposition pre-raw/raw materials, components, and finished goods

• 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

• Bachelor's degree in Life Sciences preferred but not required

Location, Environment, 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 up to 30 lbs. A typical workday is Monday through Friday from 8:00 to 4:30 or 8:30 to 5:00. Overtime may be 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-Vigify program to confirm the employment eligibility of all newly hired employees. Learn more about your rights and responsibilities under E-Vigify at www.e-vigify.gov.