QC/GMP Lab Technician (ON-SITE)

Please note that this position is on-site. Please note that this is a 6 contract position.

Education/Experience

• High School education or equivalent.
• 1-2 years in Quality Control or Manufacturing Laboratory environment.
• Experience in a medical device, high-volume manufacturing environment strongly desired.

Knowledge/Skills

• Ability to read, interpret and follow detailed procedures, instructions and drawings
• Solid understanding of QSRs/ISO
• General chemistry and laboratory skills, GLP/GMP experience
• Demonstrated team-oriented interaction skills/professional behavior
• Strong written and verbal communication skills
• Proficient word processing, data entry, and spreadsheet navigation skills
• Must know basic quality terms, definitions and concepts
• Must understand traceability (product, material, and calibration)

Interactions:

• Quality Control Chemists/Supervisor Collaborate on the development of weekly work schedules and
  maintaining timelines in meeting QC, Production, and Corporate goals. This includes both QC Chemistry
  and Sofia Test Group functions.
• Manufacturing - Communicates with various levels of personnel throughout activities performed to
  ensure results are available for disposition according to Production plans.
• Materials & Warehousing Collaborate to procure daily use materials via Stock Issue.
• R & D Ensure Quality Systems support for product development and product improvement projects,
  including validation testing, stability study execution, and documentation.
• Quality Engineering Collaborate with QE to provide factual information in a timely manner in support
  of QC process improvement and troubleshooting efforts.

Work Environment
The work environment characteristics are representative of an office, laboratory, and manufacturing
environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as
well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet
project deadlines.

Summary of Position:
This position is primarily responsible for performing Quality Control testing products at various stages of Production. This includes both routine (SOP) and special assignments, as well as documentation of findings/results for attachment to Device History Records. Additionally, this individual will lend support as necessary to the daily QC Chemistry core functions Stability Studies, Raw Material Testing, Proficiency Testing, and Customer Complaints.

Essential Functions:

• Performs and documents QC Sofia Testing of WIP Production Lots and special evaluation
  assignments
• Supports daily QC Chemistry core functions as needed
• Performs and documents 1st article functional Sofia Final Kit QC Testing
• Support new Sofia product development/improvement projects
• General housekeeping and laboratory organization
• Carries out duties in compliance with established business policies
• Works and communicates effectively and professionally with others
• Capable of working and communicating with other departments regarding testing activities
• Operate laboratory equipment safely, as trained and directed, in accordance with established
  practices
• Train new Quality Control Technicians

Candidates must provide their phone number. Job reference number is A5190.