QC Technologist I works in a cGMP environment performing quality control testing for commercial and diagnostics products. Responsibilities include conducting testing of reagents and IVD materials as well as personnel swabs. Responsibilities include working with Manufacturing, Technology Transfer and other departments for data collections and validations for new product QC qualifications, organization of quality controlled materials used for QC testing and learning new techniques or workflow as required by new product lines.
QC Technologist I is also responsible for gathering and filling out quality documents pertaining to quality control testing, generation of Non Conformance Report (NCR) when necessary and Temporary Change Order (TCO) application. QC Technologist II will be responsible for software-assisted product release (e.g. Pouch QC Web releases).
This position will work in a laboratory setting and perform a variety of scientific techniques, including spectrophotometry, PCR, pipetting, etc.
Essential Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of the BioFire Diagnostics Quality System.
- Perform quality control testing on incoming reagents used in Film Array.
- Maintain supplies as well as coordinating instrument/equipment repairs as necessary.
- Provide support if needed in other projects or validations from various departments within the company.
- Responsible for learning new techniques or workflows as required for new product lines.
- Responsible for personnel swab set up and reporting.
- Perform efficient and accurate QC data entry.
- Maintaining the QC area to ensure that it is clean and contamination-free including participation in cleaning and swabbing as assigned.
- Responsible for coordinating repeat testing.
- Works closely with QC Supervisor and colleagues to ensure consistent and timely turnaround for QC results.
- Maintain records as required by the Quality System.
- Provide training for new employees.
- Responsible for QC data review.
- Generates Non Conformance Reports.
- QC complete and release in Pouch QC Web.
- Performs troubleshooting as needed.
- Performs other duties as assigned.
Training and Education
- Associate Degree or higher in a Life Science or related field.
Experience
- Technologist I - Minimum 6 months previous experience in a laboratory setting (either academic or professional) is required.
Knowledge, Skills and Abilities
- Excellent attention to detail
- Well-developed communication skills, both written and verbal
- Highly collaborative and team oriented
- Must be mathematically competent
- Ability to effectively follow written and verbal instruction
- Demonstrated proficiency with Microsoft Office Suite
- Demonstrated proper pipetting technique
Physical Requirements
- Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).
- Must be able to lift <25lbs.
