Sr Quality Technician (A Shift)

BioFire Diagnostics; Salt Lake City (UT); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading diagnostics firm is seeking a Quality Assurance professional to ensure adherence to quality standards across departments. The role involves inspecting products, reviewing documentation, and maintaining quality records, while allowing for collaboration across various teams. Ideal candidates will have experience in QA or QC settings, a keen eye for detail, and solid communication skills.

Qualifications

• High school diploma or equivalent is required.
• Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.
• Minimum 1-year experience in Quality Assurance and a life science setting preferred.

Responsibilities

• Inspect manufactured products and raw materials for compliance.
• Review and assess processes to ensure compliance with quality requirements.
• Perform calibration and preventative maintenance on tools and equipment.

Skills

Effective written and verbal communication

Attention to detail

Organization skills

Basic math proficiency

Education

High school diploma or equivalent

Associate degree in a life science or engineering discipline

Tools

MS Office

Job description

Position Summary

The Quality Assurance (QA) department provides Quality support across various company departments. The department is organized into distinct subunits, consisting of Metrology, Document Control, Reagent Quality, Instrument Quality, Servicing Quality, and Incoming Material QC. Depending on the sub-unit, this individual may review quality records, inspect manufactured products and raw materials, perform calibration and preventative maintenance on tools and equipment, and/or maintain Quality system documents. Timely and accurate work is expected. This position builds upon the skills and responsibilities of a Quality Technician and requires an increased level of self-direction and motivation. This position regularly interacts and collaborates with other departments within the company.

Primary Duties

1. Perform all work in compliance with company policy and within the guidelines of its Quality System. 2. Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements. 3. May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned. 4. Other Duties – see relevant Appendix section

Supplemental Data

1. Minimal domestic travel may be required for training purposes

Training and Education

1. High school diploma or equivalent is required. 2. Associate degree (or higher) in a life science or engineering discipline is preferred. 3. Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.

Experience

1. Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
2. Minimum additional 1-year experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system. Education/certification in Quality Management Systems may be used in lieu of this experience.

Knowledge, Skills, and Abilities

1. Effective written and verbal communication skills. 2. Proficiency in MS Office tools, including Outlook, Word, and Excel. 3. General computer operation. 4. Attention to detail is fundamental to this position. 5. Ability to accurately follow written and verbal instructions. 6. Organization skills as needed to maintain paperwork and task schedule. 7. Proficiency in internet navigation. 8. Basic math proficiency.

Working Conditions and Physical Requirements

1. Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs.
2. 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 travel (if necessary).

Proficiently:

a. Inspect product (including labels) to specifications and established procedures. Determine product acceptance status after inspection.

b. Identify and escalate non-conformances observed during inspection. Work with production teams to resolve non-conformances where possible.

c. Ensure good documentation practices during quality document and quality record review. Report inconsistent or incorrect records to appropriate systems. Work with production teams to resolve erroneous records.

d. Physically release work in process for finished goods processing

e. File and archive quality records according to established processes.

f. Prioritize product release to meet department goals

g. Identify and report floor failures observed during sweeps of manufacturing areas.

h. Review and approve Device History Records.

i. Receive and hold finished goods inventory until release is authorized

j. Release finished goods to stock inventory k. Coordinate molded part validation inventory

l. Confirm manufacturing equipment meets requirements for release to Manufacturing Engineering for validation.

m. Confirm manufacturing equipment meets specifications for release to Reagent Manufacturing for use.

n. Control (physically and electronically) material suspected to be non-conforming Physical Requirements

1. Must be willing to submit to a color-vision test, though result of the test will not determine employment eligibility
2. Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR) as needed.
3. Must be able to perform duties in a clean room environment. This requires the use of work attire provided and laundered by the company.
4. Must be able to push, pull, bend, and/or lift at least 25 lbs, and may be required to lift up to 50 lbs., for extended periods of time on a daily basis.