Quality Assurance Officer I – TechLab

V T CORPORATE RESOURCE CTR; Blacksburg (VA); Vor Ort; USD 40.000 - 60.000; Vollzeit

Zusammenfassung

Join V T CORPORATE RESOURCE CTR in Blacksburg, Virginia, as a Quality Assurance Officer I focused on ensuring compliance with quality standards for IVD medical devices. This role involves reviewing documentation, tracking products, and overseeing quality assurance processes to improve patient outcomes.

The ideal candidate should have experience in a GMP/FDA environment and a high school diploma or an associate's degree. Additionally, a strong attention to detail and the ability to handle physical tasks are essential.

Qualifikationen

• Minimum 2 years of experience in a GMP/FDA environment if holding a High School Diploma.
• Minimum 1 year of experience in a GMP/FDA environment if holding an Associate's degree.
• B.A. or B.S. in Life Science preferred but not mandatory.

Aufgaben

• Review and track products to ensure compliance with regulatory standards.
• Issue and review Master Batch Records in support of production.
• Approve Manufacturing/Packaging Master Batch Records.
• Initiate Non-Conformity documentation and assess Quality Impact.

Kenntnisse

Experience in GMP/FDA environment

Attention to detail

Ability to lift 30 lbs

Ausbildung

High School Diploma +2 years experience

Associate’s degree + 1 year experience

B.A. or B.S. Life Science degree

Jobbeschreibung

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.

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
• Associate’s degree + 1 year of experience in GMP/FDA environment
• B.A. or B.S. Life Science degree preferred but not required

Location 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 upwards of 30 lbs. A typical workday is Monday through Friday 8:00 to 4:30 or 8:30 to 5:00. Overtime is occasionally 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‑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.