Instrument QC Technologist I/II

Job Summary  

IQC Technologist I works in a cGMP environment performing quality control testing for commercial and diagnostics products. This individual will primarily conduct quality control testing, inspection, and data reporting on manufactured or repaired products. Responsibilities include conducting testing of reagents, instruments, completing validations, environmental swab testing, and equipment calibrations. Responsibilities include working with the 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. Responsible for gathering and filling out quality documents pertaining to quality control testing and the generation of Non-Conformance Report (NCR) when necessary. This position will work in a laboratory setting and perform a variety of scientific techniques, including spectrophotometry, PCR, pipetting, etc. This position will also include visual QC inspections that require knowledge on product function. 

Essential Job Duties and Responsibilities

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Responsible for performing quality control testing on incoming reagents used in Film Array.
3. Responsible for maintaining supplies and inventory counts.
4. Responsible for coordinating instrument/equipment repairs as necessary.
5. Provide support if needed in other projects or validations from various departments within the company.
6. Responsible for learning new techniques or workflows as required for new product lines.
7. Responsible for all instrument CAL/PMs, pipette calibrations, Artel system calibration, UV hood bulbs, etc.
8. Responsible for all Film Array Contamination monitoring, collection, setup, and reporting.
9. Responsible for all other swabs set up and reporting.
10. Responsible for QC data entry.
11. Responsible for maintaining the QC area clean and contamination-free.
12. Responsible for coordinating repeat testing.
13. Works closely with QC Manager, Instrument Production leads, Service Center leads, and Reagent QC to ensure consistent and timely turnaround for QC results.
14. Responsible for maintaining records as required by the Quality System.
15. Responsible for data review, reporting, and component release.
16. Responsible for responding to inquiries and reviewing corrections.
17. Responsible for product release in Production Web.
18. Generates Non-Conformance Reports.
19. Reports daily metrics to management.
20. Performs troubleshooting as needed.
21. Performs other duties as assigned.
22. Responsible for maintaining an up-to-date pipette list within Artel system

(Instrument QC Technologist II)

1. Provide training for new employees (Instrument QC Technologist II)
2. Responsible for the installation of new fleet instrument systems

Supplemental Data 

1. This is an entry-level position within the company.
2. Must work assigned shift and have ability to work flexible schedule.
3. Must work mandatory overtime as assigned.
4. Must work full time hours as defined by the department.

Training and Education

Instrument QC Technologist I Requirements

Associate Degree in life science or related field is required. A Bachelor of Science in a life science or engineering related field is strongly preferred.
Instrument QC Technologist II Requirements
Associate Degree in life science or related field is required. A Bachelor of Science in a life science or engineering related field is strongly preferred. 

Experience  

Instrument QC Technologist I Requirements

1. 6 months experience in a laboratory/engineering setting is required.
2. Any experience in Quality Assurance or Quality Control is preferred and previous cGMP experience is strongly preferred.

 Instrument QC Technologist II Requirements
1. Minimum 2 years’ experience in a laboratory/engineering setting is required.
2. Experience in Quality Assurance or Quality Control is preferred, and previous cGMP experience is strongly preferred.

Knowledge, Skills and Abilities

• Ability to accurately follow both written and verbal instructions
• Demonstrated proficiency with Microsoft Office Suite (Outlook, Word, and Excel)
• Highly collaborative and team oriented
• Highly organized and motivated
• Effective communication skills, both written and verbal
• Very high attention to detail
• Demonstrated proper pipetting technique. 

Physical Requirements 

• Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).
• Must be able to lift at least 25 lbs.
• Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.
• Must be able to perform repetitive tasks with hands for a moderate amount of time.