Quality Specialist - Reagent Training - Biofire
Salt Lake City, UT
About the Job
This is a full-time, non-exempt (hourly) position on the Reagent Quality Assurance (QA) team with an emphasis in the Reagent Training subunit. This individual will primarily support task-based training to Reagent Quality members. This position requires a high level of self-direction and motivation. Timely, accurate work is expected. The work is fast-paced, and requires prioritization of daily tasks and attention to detail. Effective communication, written and verbal, is critical. This position regularly interacts and collaborates with other departments within bioMerieux.
4x10 Schedule (Sun – Weds, 8 AM – 6:30 PM)
Principal Job Duties and Responsibilities:
- Proficiently:
- Inspect product (including labels) to specifications and established procedures. Determine product acceptance status after inspection.
- Identify and escalate non-conformances observed during inspection. Work with production teams to resolve non-conformances where possible.
- 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.
- Physically release work in process for finished goods processing.
- File and archive quality records according to established processes.
- Prioritize product release to meet department goals.
- Identify and report floor failures observed during sweeps of manufacturing areas.
- Review and approve Device History Records.
- Receive and hold finished goods inventory until release is authorized.
- Release finished goods to stock inventory.
- Coordinate molded part validation inventory.
- Confirm manufacturing equipment meets requirements for release to Manufacturing Engineering for validation.
- Confirm manufacturing equipment meets specifications for release to Reagent Manufacturing for use.
- Control (physically and electronically) material suspected to be non-conforming.
- Review Non-conforming Product Reports (NCRs) for content, accuracy, and clarity.
- Review and decide if rework documentation meets requirements for approval and performance.
- Physically and electronically disposition NCR-related materials.
- Effectively train and mentor QA personnel on Quality Specialist and Technician duties and responsibilities.
- Plan and coordinate timing of training with respective leaders and other trainers.
- Prioritize training to meet training goals.
- Provide training of Quality Assurance procedures to Sr. Quality Technicians.
- Train or assist with training new hires on required WIDs and retrain existing employees as needed per WID and SOP.
- Determine if personnel training that has been administered is sufficient to ensure consistent execution.
- Determine trainees’ ability to retain knowledge and skills provided throughout a training.
- Communicate progress of assigned trainings to leaders and other trainers.
- Ensure documentation of the job training is completed for each skill as defined.
- Collaborate with other trainers to ensure quality and consistency of provided training.
- Process improvement:
- Draft new procedures and revise existing procedures.
- Collaborate with other teams/departments as necessary to determine appropriate instructions for Quality process.
- Ensure the inputs and outputs of Quality processes are appropriate for processes of other teams/departments.
- Conduct group training sessions for QA personnel on new and revised procedures.
- Design, develop, and implement training curricula.
Education & Experience Requirements:
- High school diploma (or equivalent) is required.
- Associate degree (or higher) in a life science or engineering discipline is preferred.
- Knowledge of good manufacturing practices (e.g., ISO 9001, ISO 13485, and/or 21 CFR 820) is required.
- Enrollment in the Salt Lake Community College Medical Device Manufacturing Program or equivalent (e.g., ASQ certification, Six Sigma certification).
- Minimum 1-year on-the-job experience requiring professional communication and interactions utilizing skills addressed outlined herein.
- Minimum additional 2-year-experience in a Quality Assurance, Quality Control, laboratory/life science or other manufacturing setting with a formal quality system (education in Quality Management Systems may be used in lieu of experience).
Skills & Qualifications:
- Effective communication skills (written and verbal).
- Proficiency in MS Office tools (e.g.Outlook, Word, and Excel) and basic computer navigation.
- Ability to accurately follow written and verbal instructions, as attention to detail is fundamental to this position.
- Basic math proficiency.
- Ability to effectively train, mentor, and coach other team members.
- Ability to collaborate with other team members in order to improve processes and procedures.
- Ability to navigate cross functional discussions, lead meetings, and propose solutions to existing challenges.
Physical Requirements:
- Must be willing to submit to a color-vision test, though result of the test will not determine employment eligibility.
- Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR) as needed.
- Must be able to perform duties in a clean room environment. This requires the use of work attire provided and laundered by the company.
- 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.
Source : Biofire
